Services: Audits-Device

For Medical Device Industry

Medical Device Info Sheet

Medical Device Consultant: Learn About our Experts

Whether you need medical device consultant support with New Product Development, Compliance Assurance, or help to navigate a 483, Warning Letter, or Consent Decree, Regulatory Compliance Associates®  can help. Our medical device consultants have a proven track record of success and can negotiate the potential minefield of medical devices with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience.

Our services highlighted in this handout include:

  • Regulatory Support for New Product Development
  • Compliance Assurance
  • Quality Systems
  • Remediation Strategy & Support
  • Strategic Consulting
  • Additional Regulatory Services

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health®

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

ISO Compliance Audit

Client

Start up Medical Device company in need of a compliance audit

Business Challenge

Scaling the client’s Regulatory Affairs and Quality Assurance team due to accelerating growth.

About QMS for Medical Devices

The FDA Quality Management System (QS) regulation applies to finished device manufacturers who intend to commercially distribute medical devices. Design controls for new product development are part of a Quality System. Within Design controls is the design history file (DHF) which demonstrates the product design was developed in accordance with the approved design plan and the requirements of the regulations (21 CFR Part 820.30).

Client Challenge

A start up medical device company needed assistance scaling their Regulatory Affairs and Quality Assurance team due to unforeseen growth. Their FDA approved Class II device received exceptional press at multiple industry events and trade shows. Additionally, the team was required to scale quickly as unit sales escalated rapidly within less than a year after product launch.

RCA’s Approach

Regulatory Compliance Associates (RCA) medical device consultants strategized about both short and long term needs of the client. Several members of the client senior leadership team work remotely outside their corporate office. Designing a program around flexibility was important to this group.

Multiple subject matter experts were assigned to provide support for each department of the remote employees. In addition, the client was engaging with a new contract manufacturer (CMO) with greater manufacturing capacity than an existing vendor. A longer-term strategy was put in place to meet growing demand and validate the new CMO’s compliance via an ISO compliance audit.

Manufacturing Support

RCA partnered with the Operations team to perform a supplier audit of the CMO during the initial scope of work. This included RCA medical device consultants reviewing the design control plan, how risk management was incorporated into outputs, a gap analysis of working instructions, and other facets of ISO 13485 compliance support.

Quality Management System

Simultaneously, a second RCA medical device consultant was engaged to partner with the Quality Assurance department. A quality management system (QMS) internal audit was conducted to validate existing standard operating procedures and design history file (DHF) documentation.

Compliance Audit

RCA’s medical device consulting services included performing a compliance audit against both the 21 CFR 820 regulation the product was originally approved for & ISO 13485 global standard. Based on the records in the common technical document, several gaps were identified for remediation. These compliance audit gaps included updates to control plans, process flows, and supplier quality agreements.

Regulatory Documentation

Additionally, establishing a more robust Device Master Record (DMR) to centralize all documents was important to the client. A product family structure was developed in the QMS to help clean legacy data & organize technical documents more efficiently.

Finally, RCA’s MDR consultants also worked with the client team to analyze the existing documentation. A project checklist was created to help with submitting any new files needed for regulatory approval in the EU based on ISO 13485.

Summary

RCA’s medical device consulting experts addressed the gaps that, once remediated, led to the contract manufacturing line being validated as cGMP compliant. The client is now working with an additional RCA compliance consultant to initiate several corrective and preventive action (CAPA) programs to address the updated internal process. Additionally, the CAPA strategy will help provide the client objective examples that corrective action prevents deviations in standard operating procedure.

Finally, the RCA medical device consulting team conducted an operations team training meeting to review regulatory compliance, cGMP manufacturing and compliance audit updates.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

Conducting an Internal Audit

The audit function of a pharmaceutical company is one cornerstone of an effective and efficient quality management system. There are several types of audits that comprise a robust auditing program including supplier audits, internal audits, and regulatory audits. Each of these specific audits requires preparation to make sure the audit is productive and accomplishes its intended purpose, which, in the manufacturing world, is to ensure facilities are manufacturing fit-for-use products in full adherence (hopefully more) to current good manufacturing practice (CGMP) requirements.

 

Supplier audits are performed to confirm that the suppliers of raw materials, packaging, and labeling components, etc., are able to provide a continuous, uninterrupted supply of materials that are compliant with CGMPs. Regulatory authorities perform inspections to determine if the manufacturing company is providing materials that comply to CGMPs. Internal audits are performed by the company as a self-assessment for the purpose of identifying areas/issues that might affect their compliance status.

 

Pre-pandemic, preparing for a supplier or regulatory audit typically consisted of the regulatory inspector or the auditor for supplier/internal audits providing the facility being audited with an agenda listing the areas to be toured (e.g., incoming raw material area, quality control [QC] chemistry and microbiology laboratories, manufacturing, etc.) and a list of documents to review (e.g., quality manual, list of standard operating procedures, open deviations, and corrective and preventive actions [CAPAs]) and any additional supporting evidence the auditor chooses to review. This information helps auditing authorities assess and decide the compliance status of the facility.

 

Performing external audits during a pandemic

The documentation that would have been reviewed on-site pre-pandemic is the same documentation that is needed for review during and post the COVID-19 pandemic. The documentation and supporting evidence review conducted pre-pandemic would most likely have occurred at the facility. However, audits conducted during the pandemic require the documents and supporting evidence to be shared electronically to the auditor using secure electronic systems. This electronic exchange helps make time more efficient for both the auditor and the facility being audited. The documentation can be reviewed by the auditor, and questions can be communicated to the audit manager via email or conference/video calls. While this may not be ideal, because it eliminates the in-person interaction, it is still an effective way to conduct an audit when there are conditions prohibiting face-to-face interaction.

 

Touring the facility is challenging when the audit is conducted during a pandemic, but challenges can be overcome with some flexibility and ingenuity. Live video feed could be streamed to the auditor while the company’s audit manager and/or subject matter experts are available to answer questions that might arise during the live feed. Additionally, operations could be recorded, and that recording could be provided to the auditor, again with the understanding that the audit manager would be available to answer any questions posed by the auditor upon the review of the video. While the recorded version of the tour is probably not the most ideal, because the auditor needs to see things in as real time as possible, it does allow for the auditor to pause and go back to review a specific operation in more detail if warranted.

 

Internal audits during a pandemic

Preparing for an internal audit requires the same discipline as preparing for supplier and regulatory audits. During the COVID-19 pandemic, many companies reduced the number of employees allowed at the site, and many of the quality personnel that conducted audits were allowed to work remotely. Internal audits are part of management responsibilities (1–3) and must continue to be performed, even during a pandemic.

 

Conducting an internal audit is different from the other audit types, whether it is pre-, during, or post-pandemic. If designed and implemented appropriately, the value of the internal audit is that it allows the company to find vulnerabilities in their systems and remediate them before they are discovered by an external auditor. Internal audits can provide valuable information that can be used to prevent issues before they become compliance concerns. If these issues can’t be completely remediated before an external audit, a plan to correct them can be established and action taken to mitigate them. Having corrective actions in place before others identify the issue may lessen the impact of the observation and instill confidence that your quality system is under control and there is a process in place for continuous improvement. In addition, the internal audit can be used for training staff and communicating valuable information to the organization.

 

The ideal tone for an internal audit should be a collaborative team-oriented activity that is instructive, informative, open, honest, and inclusive. There are several factors that help contribute to establishing this tone, even during a pandemic. One way to set the proper tone is to publish the audit schedule/agenda in advance and make sure the functional areas personnel are informed of the schedule. During a pandemic, the agenda takes on another level of importance because it ensures that the site can have the proper documents ready to go and upload them either before or during the audit. Prior planning precludes poor performance in this area.

 

The auditors should work with the functional area and talk with as many employees as possible to identify the issues of concern. Individuals who are responsible for performing the day-to-day activities often have the best insight as to what is working and what needs to be improved. Excluding them from participating in the audit process might result in overlooking a serious issue that could come up during a regulatory inspection or inadvertently lead the auditor to think the site is hiding something. To be able to get the most valuable information about the potential compliance issues facing the organization, internal audits should not be judgmental or antagonistic, or have a ‘check the box’ mentality in execution.

 

Auditors should be direct and avoid asking questions designed to intentionally stump people. Another important behavior is the ability of the auditor to listen to the answers personnel give and refrain from judging. The exact same behavior defined for the auditor should also be the exact same behavior displayed by the auditees. Auditees should be direct and avoid deflecting or obfuscating answers and take the time to explain why they do things the way they do them. They should be proactive and point out things of concern and seek advice on how to remediate them. Both parties need to remember they are not enemies, rather they are the partners in improving their organization together.

 

Conclusion

Conducting audits during the pandemic has presented a multitude of challenges. The pandemic has allowed the industry to creatively utilize technology-based applications to communicate and perform an effective audit. The documentation and supporting evidence review can be conducted remotely, and confidentiality can be maintained. After reviewing the documentation and supporting evidence, the auditor can request interviews with various personnel, which can then be scheduled via video conferencing.

 

With appropriate planning and the proper use of technology, remote auditing can be as effective and informative as in-person auditing. The post-pandemic sweet spot will likely be balancing remote and in-person audits.

 

 

BioPharm International

Vol. 34, No. 2

Pages: 44-45

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

Audit Trail: Risk-Based Approach to Compliance

With the rapid evolution of technology, more and more companies in regulated industries have transitioned to an electronic medical device audit trail. This was the impetus for the U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 regulation, which states that electronic records and signatures are equivalent to paper record and handwritten signature.

 

Compliance with the regulation requires that a digital signature be assigned to a specific individual, include a signature type (i.e., review, approval, author), and be traceable from the document back to the signer.

 

 

To ensure the transparency, trustworthiness, and reliability of records, regulatory oversight of a company’s data and records management includes examining timestamped audit trails. GxP Lifeline recently met with Seyed Khorashahi, executive vice president of medical devices and CTO at Regulatory Compliance Associates (RCA) — a worldwide consulting firm that assists pharmaceutical, biologic, sterile compounding, biotechnology, and medical device companies with resolving compliance and regulatory challenges. Khorashahi shares some valuable insight on the anatomy of a medical device audit and advises companies on how to comply with this critical component of Part 11.

 

Medical Device Audit

 

Bottom line, an audit trail is the who, what, when, and why of a company’s data. It’s a log containing metadata that essentially allows you to reconstruct all user actions and events. As a result, the accuracy of the data will show who made a change and what was changed. And when it was changed. And, more importantly, why.

 

Part 11 includes the predicate rules, which apply to record retention throughout the product’s life cycle — from cradle to grave. An audit trail ensures the ongoing completeness, accuracy, integrity, and security of data and records. It’s also necessary to provide transparency of the actions people take with the data. This all needs to be available to auditors during an inspection.

 

Audit Tracking

 

Manufacturing regulated products calls keeping a close eye on tracking product data — especially when it can impact on patient safety. This can be tricky in the day-to-day gathering, storage, tracking, usage, etc. of data.

 

Good Documentation Practices (GDP) mandate that you document everything in regulated product development. This help provide supporting evidence during audit tracking that employees are following procedures. An important component in a medical device audit is data needs to be timestamped. Therefore, data needs to be in electronic form. Companies still using paper records need to digitize documents in order to file and track them electronically.

 

Document Scanning

 

When scanning materials, clarity is critical to field audit tracking. Text-only documents can be simple enough, but images are more difficult. You need the ability to capture everything to ensure it’s a true copy that is acceptable under GxP regulations.

 

Beyond that, scanning stacks of documents is prone to its own set of challenges. Not only is it extremely time-consuming, all scanned documents need to be reviewed. This ensures there are no errors or missing pages at the end of the medical device audit. Then the same Part 11 signature guidelines need to apply.

 

Another challenge is the audit trail software that companies use for managing quality processes and data are configurable. This means they might not have a way to limit access to specific users or revise permission access. Above all, leadership employees should employ controls for the inadvertent deletion of data. This directly puts data integrity at risk.

 

Medical Device Cybersecurity

 

Also, if they’re using an open system (connected to the network), it becomes a cybersecurity concern because open systems have a wider cyberattack surface. Hackers continuously employ various human and computer-generated measures to gain access to a company’s data. Once data is breached, it’s no longer compliant with data integrity requirements.

 

There are also situations where employees undermine medical device audit trails by sharing login credentials. This has actually been noted in both warning letters and the audit trail report. Community system access may be a common workaround to keep production going when key personnel are away.

 

However, going back to the who, what, when, and why concept, when an entire department uses the same username and password, there is no way to accurately trace actions to specific individuals or verify electronic signatures.

 

Audit Trail Compliance

 

As I mentioned earlier, at the end of the day, data stewardship is all about keeping track of who, what, when, and why. Companies are collecting and handling more data these days. This means there is a lot more information to keep an eye on. Data has a certain life cycle based on the type of product.

You need to make sure you have a validated system and processes in place to ensure it remains intact, secure, and readily accessible for audits.

 

  • Electronic signatures – Are electronic signatures unique to the individual? Ensure that signatures cannot be copied or transferred.
  • User credentials – Is user access tightly controlled based on each person’s role and job responsibility? For example, people who access and modify data should not be able to turn off or modify the audit trail. Having too many users with read and write access to data increases the risk of intentional or inadvertent data changes or loss.
  • Audit trail reviews – Are audit trails getting reviewed often enough and by the right people? Part 11 guidelines specify the audit trail review requirements regarding who and how frequently they need to be reviewed. This is necessary to ensure records are accurate, free of gaps and errors, and that the information provided to auditors matches what is in the system.
  • Escalation – Are only authorized personnel reviewing and approving records? There are occasions when an approver is unavailable. There should always be another person who is authorized to approve and sign records. The system needs to include the functionality and procedures to allow the escalation of document reviews and approvals to other authorized individuals. These situations also need to be logged and documented.
  • Security – Are there system vulnerabilities that could lead to a security breach? I touched on security earlier, but I can’t emphasize enough the importance of system and data security. Even before COVID-19 dispatched employees to work remotely, many companies were incorporating mobile devices. This increases security vulnerabilities. Using an integrated QMS that has security measures such as role-based authentication and access controls can effectively augment data protection processes.

I recommend using a risk-based approach with audit trails. Your quality management system (QMS) and processes can identify and resolve the risks to data integrity. Here are a few items to consider when doing a risk assessment and being compliant with Part 11:

 

Digitization is the direction things are going. You need to be able to effectively control and rely on your data. And legacy and hybrid systems won’t always be compatible with the evolving regulatory landscape. Companies in regulated environments need to make sure their data and metadata are compliant with data integrity requirements. Data access should be transparent and accessible to future medical device audit team members, including in a readable format for the extent of the data’s life cycle.

 

About RCA’s Medical Device Consulting Services

 

The regulatory compliance process surrounding the medical device industry involves a strict adherence to pre/post market information throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. Regulatory Compliance Associates medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

 

Our team of over 500 medical device consulting Experts — including former FDA officials and regulatory compliance leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. Regulatory Compliance Associates works with international Fortune 100 companies, venture capital start ups, and companies of all sizes and shapes. our compliance enforcement solutions for law firms include remediation for warning letters, FDA 483’s, import bans or consent decrees. Very few regulatory compliance services have the same regulatory compliance expertise in a variety of medical fields.

 

Cybersecurity

 

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if Regulatory Compliance Associates medtech consultants do not implement good IoT cybersecurity and FDA cybersecurity protocols.

 

At Regulatory Compliance Associates, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks. With a well-planned design, along with full visibility of product development and the supply chain, Regulatory Compliance Associates medical device consultant Experts can help strengthen your device’s cybersecurity. We partner with medical device companies in each phase of the design cycle, including protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval of your medical technology.

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. Our regulatory compliance consulting Experts have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

 

As a trusted regulatory affairs consultant, our FDA veterans and industry experts represent Regulatory Compliance Associates® as one of the top medical device consulting firms. We’re here to help you navigate the difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support. 

 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR
  • Combination Products

 

Compliance Assurance

 

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® can help.

 

Our network of over 500 medical device consultant & FDA, MHRA & EMA veterans are industry professionals offers a unique blend of expertise. This allows Regulatory Compliance Associates® to handle both simple and complex regulatory compliance challenges within medical device consulting companies.

 

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response
  • Data Integrity

 

Quality Assurance

 

Regulatory Compliance Associates® Quality Assurance consulting includes quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At Regulatory Compliance Associates®, we offer you the quality assurance services you need to monitor these processes and ensure quality compliance every step of the way.

 

With more than 20 years experience working with medical device consulting companies, Regulatory Compliance Associates® trusted medical device quality assurance consultant team is fully equipped to handle your unique QA needs.

 

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation
  • Quality Metrics

 

Remediation Support

 

Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for remediation support. Regulatory Compliance Associates® ability to help companies successfully resolve complex regulatory challenges have a proven track record of success. Our medical device consulting services include significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

 

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our medical device consultant expertise and experience that makes partnering with Regulatory Compliance Associates®  a competitive differentiator in the remediation space.

 

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP

 

Strategic Consulting

 

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® medical device consultancy can help ensure a successful project. Regulatory Compliance Associates® medical device strategy consulting can deliver your project on time, on budget, and you’re never embroiled in a costly mistake.

 

Our medical device consultant Experts are industry Experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

 

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Risk Management Plan
  • Product Complaints
  • Medical Information

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides medical device consulting to the following industries for resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

Commitment to Quality

 

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

FDA Medical Device Services

Audit, Assessment & Inspection Services

A regulatory audit and compliance gap assessment are essential in identifying product, process and system deficiencies, risk assessment, and inspection readiness. Our FDA veterans and medical device consulting experts use a gap assessment risk-based approach to help you select the best FDA audit or inspection solutions.

 

About RCA’s Medical Device Consultants

The regulatory process surrounding the medical device industry involves a strict adherence to pre/post market compliance throughout a device’s life-cycle. Even a single compliance issue you have can turn into a significant effect on your business. RCA’s medical device consultants can help guide you through any stage of this strategic process, with capabilities during product development through the regulatory clearance/approval of your product.

Our team of over 500 industry experts — including former FDA officials and other leaders in the field of medical device regulation — will work with your company to create a quality assurance and regulatory compliance approach tailored to your products and regulatory needs. RCA works with both international Fortune 100 companies and small local start-ups, as well as law firms requesting remediation for warning letters, 483’s, import bans or consent decrees. We offer expertise in a variety of medical fields, such

 

Cybersecurity

For medical device manufacturers, technology can be a double-edged sword. The innovative technologies that elevate the quality of life for patients can also be used to potentially undermine the organization using the device. The consequences can affect the device itself if we do not implement good IoT cybersecurity and FDA cybersecurity protocols. At Regulatory Compliance Associates Inc.®, we offer a wide variety of services for medical devices security to help ensure that your product is protected from cyber-attacks.

With a well-planned design, along with full visibility of product development and the supply chain, RCA can help strengthen your device’s cybersecurity posture throughout. We partner with medical device companies for the entire life cycle, including from the development of your product to the regulatory submission to your notified body.

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates® Inc.’s backbone, and we handle more submissions in a month than many manufacturers do in a lifetime. We have experience working with the FDA, global regulatory bodies and / or agencies, and notified bodies worldwide. Therefore, you can count on us for in-depth and up-to-date insights which increase speed-to-market.

As a trusted regulatory affairs consultant, our FDA veterans and industry experts are here to help you navigate the difficulties associated with new product submissions. They have expertise in both the approval process and post-approval support. 

  • New Product Approval
  • Post-Approval Support
  • Outsourced Staffing
  • EU MDR

 

Compliance Assurance

Increasingly, life science companies are feeling the pressure of greater scrutiny by regulators, and responding by developing sustainable compliance strategies. Whether it’s preparing for an audit, developing a response to an FDA finding, or remediation to an adverse event, Regulatory Compliance Associates® Inc. can help.

Our network of over 500 FDA veterans and industry professionals offers a unique blend of expertise that allows us to handle both simple and complex regulatory compliance challenges within the medical device industry.

  • Gap Assessments
  • Internal Audits
  • Employee Training
  • Notified Body Response

 

Quality Assurance

Regulatory Compliance Associates® Inc.’s Quality Assurance services include quality system assessments, strategy, implementations, and identification of quality metrics to ensure continuous improvement, aligning with your business needs and goals. Our consultants are quality experts with experience spanning major corporations and start-ups. We know firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

In the medical devices field, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device is sent to market. At RCA, we offer you the assistance you need to monitor these processes and ensure quality compliance every step of the way.

With more than 15 years of experience as a trusted medical device quality assurance consultant, our team of over 500 industry experts and FDA veterans is fully equipped to handle your unique QA needs.

  • ISO13485 
  • 21 CFR 210
  • 21 CFR 211
  • Outsourced Staffing
  • MDSAP
  • Facility Validation
  • Equipment Validation

 

Remediation Support

Regulatory Compliance Associates® Inc. is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges, including remediation. With a proven track record of success, we have significant experience with the development of responses to 483 Observations, Warning Letters, Untitled Letters and Consent Decrees.

Our value goes beyond the initial response by helping companies successfully execute their action plans, develop an improved compliance culture tailored to the needs of their business, and ultimately move beyond the regulatory action to emerge as a stronger business. We negotiate difficult demands of remediation with insight and the clear advantage of our unique expertise and experience that makes partnering with RCA® Inc. a competitive differentiator in the remediation space.

  • Quality System
  • Technical File
  • Design History File
  • Data Integrity
  • cGMP 

 

Strategic Consulting

Whether it’s a strategy, a technical plan, or project, Regulatory Compliance Associates® Inc.’s worldwide experience can help ensure a successful mix of people and product so your project is on time, on budget, and you’re never embroiled in a costly mistake.

Our 500 industry and FDA experts are here to provide the unique insight you need before an M&A deal, through a staffing crisis and in every area of your product’s development and life cycle. As the trusted medical device manufacturing consultants of thousands of companies around the world, we have the knowledge and expertise needed to deliver exceptional results to your business — no matter your size or unique needs.

  • Manufacturing Optimization
  • Product Lifecycle Management
  • Mergers & Acquisitions (M&A)
  • Due Diligence
  • Device Vigilance
  • Product Complaints
  • Medical Information

 

About RCA®

 

Regulatory Compliance Associates (RCA) provides medical device consulting to the following industries for the resolution of life science challenges:

 

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA, and globally regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health®

 

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

FDA Inspection: Remote vs. In-Person

Learn more about remote inspections, FDA inspection training and begin preparing now for next year’s FDA remote inspections.

 

“Physical inspections, especially when unannounced, are one of FDA’s most important tools to ensure drug safety and quality.”

 

REPORT 117 (2021): AGRICULTURE, RURAL DEVELOPMENT, FOOD AND DRUG ADMINISTRATION, AND RELATED AGENCIES APPROPRIATIONS BILL 

 

There will be a live demo of the world’s first multi-party immersive remote presence service by Avatour, as well as a breakdown of the U.S. House Appropriations Committee recently submitted an increase in budget for the Food and Drug Administration (FDA), including new funding for increased on-site inspections during 2022 and beyond. 

Earlier reports  also documented the incremental funding may be utilized for additional headcount to support the return to a normal rate of unannounced in-person FDA inspection events. International markets, including India and China, have also been mentioned as regions of interest due to previous 2020 travel complications due to the global COVID-19 pandemic.

In this webinar you will learn more about:

  • How the FDA will utilize remote inspections in the future based on these changes
  • Proactive companies who set compliance training exercises for their FDA inspection teams
  • Considerations for revising standard operating procedures based on virtual compliance
  • Virtual Audit Solutions for conducting training inspections similar to an FDA Audit
  • Take a virtual tour of the fastest growing remote inspections technology, Avatour
  • Best practices for partnering with the FDA during an unannounced inspection

 

Presenters

Devon Copley

CEO and Co-Founder of Avatour

An expert on live immersive technology, Devon has more than 20 years of experience in online media and VR. Previously, he was Head of Product for the Nokia OZO VR platform, where he expanded the OZO ecosystem to include live VR broadcast, next-generation immersive delivery, and multi-platform playback. Earlier, Devon co-founded the online media consulting firm Interocity (acquired by Chyron) and was VP of Customer Success at the leading cloud video platform Kaltura. Avatour is a new form of communication: the world’s first multi-party immersive remote presence service.

Remote Inspections

Eric Januszewski

Senior Director, Client Relations

As Regulatory Compliance Associates® Inc.’s Senior Director of Client Relations, Eric has focused on assisting European medical device and pharmaceutical companies gain market entry into the United States, helping provide solutions to increase market growth while focusing on quality and compliance. His experience includes providing support to a broad range of companies in operations, FDA and EU compliance management, change control processes, and audit preparation. Regulatory Compliance Associates® Inc. (RCA) provides worldwide solutions to the medical device and pharmaceutical industries for resolution of regulatory, compliance and quality challenges.

 

About RCA’s Pharmaceutical Consulting Services 

Regulatory Compliance Associates (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by regulatory compliance executives from the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates team knows the unique inner workings of the regulatory process. 

 

Client Solutions

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates will guide you through every pharmaceutical consulting step of the regulatory process. Our pharmaceutical consulting Experts will create a customized approach depending on your product and company’s individual needs. Our regulatory compliance clients include:

  • Companies new to FDA, Health Canada or EU regulations and regulatory compliance
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

Regulatory affairs is Regulatory Compliance Associates backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs. Additionally, we specialize in Regulatory Support for New Products to Life Cycle Management, Outsourced Regulatory Affairs, Submissions, Training, and more.

As your partner, we can negotiate the potential assessment minefield of regulatory compliance services with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and regulatory compliance consulting. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services
  • Combination Products

 

Compliance Assurance

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates, we offer the pharma consulting experience and pharma consultants necessary to guide you an FDA inspection & quality compliance process.

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness
  • Data Integrity

 

Quality Assurance

Regulatory Compliance Associates Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals. Regulatory Compliance Associates quality assurance services include quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality. Finally, our regulatory compliance services team excels in transferring continuous improvement knowledge to your organization.

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support
  • Quality Metrics

 

Remediation Services 

Regulatory Compliance Associates has significant experience and a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams. Each RCA pharma consulting Expert will develop a response that will be accepted by the regulatory agency and be realistic to execute.

Regulatory Compliance Associates pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues. In addition, each Regulatory Compliance Associates pharma consulting Expert understands FDA inspection & compliance enforcement. We’ll prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain regulatory compliance with the regulations.

  • Regulatory Action
  • Regulatory Compliance
  • Regulatory Enforcement
  • Warning Letter
  • 483 Observation
  • Oversight Services
  • Risk Management Plan

 

About Regulatory Compliance Associates

fda inspectionRegulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

  • Founded in 2000
  • Headquartered in Wisconsin (USA)
  • Expertise backed by over 500 industry subject matter experts
  • Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health®.

Sotera Health Company, along with its three best-in-class businesses – Sterigenics®, Nordion® and Nelson Labs®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

We are a trusted partner to 5,800+ customers in over 50 countries, including 40 of the top 50 medical device companies and 9 of the top 10 pharmaceutical companies.

 

Commitment to Quality

Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.