Click now to hear from Jordan Elder, RCA’s Director of Regulatory Affairs, regarding the latest info on Quality System Regulation (QSR) regulations and FDA harmonization efforts:
When developing a quality management system (QMS), it is important to understand any pitfalls that could arise as well as understand what each notified body looks for in a compliant quality system. Recently, one of the US Food and Drug Administration’s (FDA’s) top medical device regulators said harmonizing the agency’s current Quality System Regulation with the International Organization for Standardization (ISO) 13485:2016 is a “high priority”.
Click to learn about the latest updates to the QMSR File Rule.
QMS Harmonization
Currently, the US Food and Drug Administration (FDA) does not enforce ISO’s 13458:2016 standards set in place for Quality Management Systems, but uses its own Quality System Regulation (QSR) guidelines that do include parts of the 13458 standards. But this is set to change for the better. The FDA has recently proposed plans to align its quality system requirements with ISO 13485:2016, creating a new regulation dubbed the Quality Management System Regulation (QMRS). This shift came four years after the agency first proposed the regulatory alignment.
Quality Management System
Manufacturers who already conform to the ISO standard should not see much change and this move should help create efficiencies for them in the long run. The FDA proposed the alinement by incorporating the 2016 edition of the international standard specific for medical device quality management systems ISO13485. Through this rulemaking, the FDA is also proposing additional requirements that help connect and align ISO13485 with existing requirements in the FD&C Act and its implementing regulations. This will include making conforming edits to 21 CFR Part 4 to clarify the device CGMP requirements for combination products as well.
Risk Management
The most noticeable difference between the current quality systems regulation and ISO13485 is that the risk management requirements are integrated throughout the aspects of the quality management system in ISO13485. This differs from 21 CFR 820, in that the only risk-specific requirement in the QS regulation is listed in §820.30(g), as it relates to risk analysis as a part of design validation.
These revisions are intended to supplant the existing ISO13485 requirements with the specifications of an international consensus standard for medical device manufacturers. The revisions are expected to reduce device manufacturers’ burdens, specifically aspects of compliance and recordkeeping through the harmonization of domestic and international requirements.
ISO Standard
With a membership of 168 national standards bodies, ISO is an independent, non-governmental international organization that brings together experts from around the world to share knowledge and develop voluntary, consensus-based, market-relevant International Standards that support innovation and provide solutions to global challenges.
Although the standers set by ISO are recognized by organizations around the world, ISO compliance itself isn’t a legal requirement, the standards naturally align with different regulations across the industries. ISO compliance means using ISO standards as guidelines for aligning your policies, processes, and operating procedures to adhere to the standard.
ISO 13485:2016 specifies requirements for medical device quality management systems where an organization needs to demonstrate its ability to consistently meet customer and applicable regulatory requirements. This includes one or more stages of the product life cycle, including:
Design controls and development
Production and manufacturing
Storage and distribution
Installation
Servicing a medical device
Technical support
ISO13485:2016 can also be used by suppliers or external parties that provide products, including quality management system-related services to such organizations.
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.
Measuring the impact of the FDA’s Regulation Proposal
With recent developments in technology, we have seen artificial intelligence and machine learning more commonly used across all aspects of our lives. Whether it’s our phones or smart speakers, this dynamic technology has applications in all industries, including the medical device industry. To ensure AI in medical devices can evolve while still protecting patient well-being and safety, the FDA recently released new information about its plan to regulate developments.
Looking to Implement AI into your Medical Device? Contact Us Now →
Artificial Intelligence vs. Machine Learning
Artificial intelligence and machine learning are two similar terms people commonly use interchangeably when discussing this type of software or technology, but they actually mean different things.
Artificial intelligence refers to any kind of technology deemed to be “intelligent,” or capable of understanding new data and adapting its functions accordingly. Machine learning refers — not to the device or software itself — but rather to the method scientists use to “teach” software to adapt to new information through learning and updating stages. Usually, machine learning is applied in the form of decision trees, where a certain action will always lead to a certain response and each action after follows a set path.
Researchers are now using machine learning to improve the efficiency of AI in medical devices. Practitioners often use different kinds of software to help them examine and treat patients, and AI as a part of medical device software is growing a little more every day. Machine learning allows AI devices to monitor patients, improve medical imaging software and even the potential to deliver certain treatments to patients.
However, AI doesn’t learn the same way humans do. AI software and algorithms are taught to adapt based on statistics and patterns they gather from experience. This capability means AI medical devices have the potential to develop very quickly as they receive and analyze risk management data in real-time and in real-life applications.
FDA Concerns About Artificial Intelligence in Medical Devices
There are two main types of technological algorithms:
Locked algorithms: only understand information and analyze it based on the way they were programmed. If you ask a locked algorithm a question or input certain data, it will always offer the same solution or result.
Adaptive algorithms: can respond and recognize new patterns or opportunities as it receives new data, and adjust it’s process or response accordingly.
Adaptive algorithms in medicine are currently causing the FDA the most concern. When companies that create software or medical devices give AI-based programs or products the freedom to examine or help treat patients by allowing them to respond to real-world situations and data, they have less control over what the AI learns and how it uses that information to adapt. If left unchecked or under-regulated, this could pose the possibility of changes developing that could create patient risk.
The FDA is currently working to develop a framework that will allow for the safe use of ever-adapting AI in the hospital setting. To make sure patients stay protected, FDA representatives have indicated that if an AI medical device is approved, it would have to be monitored constantly for changes in its algorithm. Making sure all the information the AI absorbs and analyzes stays transparent and malleable is crucial for maintaining a secure healthcare practice.
Challenges of Implementing AI Medical Devices
Another concern that artificial intelligence medical devices FDA regulations will address is helping AI respond better to individual patients. Unfortunately, there is no one-size-fits-all approach. Some illnesses or conditions may affect people differently.
This means some situations might confuse an AI machine or cause it to not analyze things properly. Researchers and the FDA must account for such gray areas and variables that could cause an AI device to malfunction or compromise the safety of patients. Programming an AI algorithm to understand cause and effect or to strategize using a decision tree can’t account for all potential factors.
The Future of AI in Medical Devices
The FDA is working to develop appropriate regulations for the use of Software as a Medical Device. Products that are driven by AI software or processes fall under this category, but given their unique ability to adapt to new data, they likely require separate scrutiny. As AI continues to evolve in the coming years, the FDA will have to keep a close watch on its applications and uses in the medical field to ensure patient protection.
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 can help guide you through any stage of the medical device consulting 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.
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 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.
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.
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.
Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & 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.
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
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.
Developing a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements you should consider for your team during crisis handling & developing a crisis management playbook.
Risk Management
Being able to identify factors that impacted product safety or regulatory compliance is one of the most important elements during the risk assessment phase. During RCA’s risk management services process, operational risk management is one of the first remediation steps to consider.
Identify Risk
Being able to identify the product hazards that caused the crisis is critical to understand scenario planning. Conduct due diligence to ensure that your product design outputs include no risks that are unnecessary to the consumer. Hazards that do include one or more risk factors must be analyzed why the patient benefit exceeds the financial risk.
Measure Risk
During scenario planning, identify the critical elements to measure your team and results by via a risk management framework. A risk profile for each product in question can support evaluating, reporting and monitoring adverse events. Systemic risk should be analyzed for product risk profiles with longer term, reoccurring events or specific pharmacovigilance indicators identified as proactive crisis control.
Mitigate Risk
Being able to work clearly and concisely with your regulatory agency is critical for the due diligence solutions presented for review. Examining all hazards that have been identified during the risk mitigation phase is essential to success during the risk management process. Consider any of the threats that are regarded as acceptable with known risks and document unusual activity in your risk management plan.
Crisis Management Communications
An initial step recommended by RCA’s medical device consulting team is to identify and evaluate the regulatory compliance dangers and situations. For example, assessing the vulnerability of medical device cybersecurity must consider internal and external threat modeling. Any type of cyber breach that might impact your operations team, business reputation, or stakeholder relationships should have a detailed communication strategy.
Crisis Communication Plans
A veteran RCA medical device consultant suggests developing a universal shared space where team members can bookmark & access the crisis comms document. A communication strategy would then be shared with communication partners engaged in the public relations and crisis management campaign.
Risk Management Communications
Inside a successful crisis communication team, everyone knows their role and responsibilities. RCA’s regulatory consulting Experts often designate a process leader who clearly understands the team stakeholders and functions they represent. Refine your approval process so that messaging not only meets external approved communications from these stakeholders, but also legal concerns.
Crisis Control
A detailed risk management communication plan helps specify different examples for sharing risk messaging to either internal audiences or external stakeholders. Design your communication plan templates so that information is easy to understand for multiple audiences. Different types of tactics to be considered for templates (e.g. press release, social media) to confirm the messaging reliability of the crisis communication strategy.
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. You may also email us at [email protected].
Click to watch Regulatory Compliance Associates medical device consultant, Dr. Stephen Coulter, discuss the common tools & processes used during product development. Early stages of new product development include analyzing user needs & translating design benefits into long-term patient efficacy.
Developing an original product idea is difficult but many common tools & processes are consistently used. The early stages of product development include analyzing user needs and how those translate into design inputs.
Product Development Strategy
Ideation and product development life cycle research can help you identify user needs. Additionally, increasing the quality of an existing product is often a successful new product development strategy. Your solution doesn’t have to be a radically new idea.
Does it have a substitute product that can take market share? Or, can you combine the features of multiple products during the product design process to make a combination product that patients prefer more? Could a product design consultant help answer these questions & provide knowledge transfer?
Product Development Cycle
Start by asking your cross-functional team an initial question: “What do we need to change to achieve success during the product development cycle?”. Product development strategy includes modifying existing systems & processes to accelerate efficiency. Refine your model or process based on the unique types of product solutions in your pipeline.
Product Research
Being able to understand & explain why your solution addresses a user needs statement is inherent to launch sales success. Interactive activities can be useful for improving creative conversation during market development strategy sessions. Further, voice of the customer (VOC) research consistently helps target the patient population in mind.
Finally, using VOC to identify early adopter audiences & the audience’s most important needs can increase early interest in your solution. Begin the sales process by determining core messaging ahead of the launch ramp-up based on device claims & if the regulatory submission is approved.
Market Development Strategy
User needs are the foundation of any successful market development strategy. Yet, being able to commercialize a new solution based on user needs using a team experiencing process problems is never an easy task. It requires the Engineering Team & Operations Team at the listening table earlier in the process than later.
Product Design and Development
A critical to quality objective early in the new product development process is removing everything but the essentials. Research your users needs to create design inputs for a product that patients both need & generates revenue.
Product Planning Process
After a business case is determined in the waterfall method, the product planning process begins cross functionally to validate product ideas via new product development research. What user needs will accelerate a successful product launch the fastest?
Innovative product design means addressing honest opinions from your target audience to validate your medical device solves a problem. The product development management team must be convinced the product can win in the commercial marketplace sooner rather than later.
Software Product Design
Success during the launch of a software as a medical device is often found at the heart of the product development plan. Any new product design must incorporate value added for the audience in one way, shape or form. This can include lean product design as some of the most effective software in the industry is not complicated.
Software as a Medical Device
Consider the regulatory differences between a tangible product and a technology product very carefully. For example, Software as a Medical Device (SaMD) has changed the marketplace by increasing both clinical research success & primary care delivery. Include process improvement sessions during internal meetings where a collective group deciphers what the user need statements mean to their team.
Agile Product Development
The vision for development begins with a minimum viable product, or MVP, during early software conceptualization & development; what is the business case of commercialization? How do we learn faster while making real time efficiency changes?
Digital Product Development
Product development teams must answer several questions before undertaking product design. Further, one focal ask is are successful processes already in place for medical product development.
Do you have a RACI chart to show who is responsible, accountable, considered, and informed? Finally, a clear cross-functional understanding of timelines & milestones can help guide expectations during MVP product development, which can be stressful based on the speed of common work.
MVP Agile
MVP (Minimum Viable Product) a widely accepted concept in software development in digital product development. However, our medical product design discussion will take a different direction – what is the regulatory affairs process?
A project management software development team should deliver a safe, efficacious solution with the objective of delivering patient value. Define your value through a regulatory strategy based on device claims, clinical evidence, and how both help the patient population.
Regulatory Compliance
Software as a medical device involves regulatory compliance based on multiple, widely accepted global standards.
This includes:
ISO 13485
IEC 62304
IEC 62366
ISO 14791
The product development engineering team is responsible for the software process. Any prototype development assistance should begin with a regulatory compliance perspective of claims and predicate devices.
Prototype predicate concepts begin with identifying the current risk class & why use cases help validate your proposed risk class during regulatory submission. Finally, consider younger product developers who may have never been through regulatory approval in their career. FDA readiness training can be a powerful tool that increases marketing approval & how to carefully identify and isolate risk hazards.
Regulatory Pathway
Planning the build for a product requires a regulatory pathway that includes risk management considerations based on the risk class. Create as much detail as possible during this prototyping and design inputs phase of NPD.
Product development companies, like Regulatory Compliance Associates, can help identify the correct predicate device based on a risk gap analysis. Diagrams should include material ingredients that need to be sourced to create the product. This can help you determine the risk category of the product (e.g. patient daily use, HCP specialty use, etc.) and corresponding patient hazards.
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 can help guide you through any stage of the medical device consulting 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 regulatory compliance 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.
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. The RCA medical device consulting team understands protecting inputs from threat exposure and hardening outputs for regulatory compliance & FDA submission approval.
Regulatory affairs is Regulatory Compliance Associates® backbone. We handle more regulatory consulting 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 regulatory consulting team represents Regulatory Compliance Associates® as one of the top medical device consulting firms. We’lll help you navigate the medical device consulting difficulties associated with new product submissions. Regulatory Compliance Associates® medical device consulting company has expertise in both the approval process and post-approval support.
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.
Regulatory Compliance Associates® is globally reknown for quality assurance services, including quality system assessments, strategy, implementations, and quality metrics to ensure continuous improvement. Each Regulatory Compliance Associates® medical device consultant is a quality expert with experience spanning major corporations and start-ups. RCA’s quality assurance services experts 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.
Regulatory Compliance Associates® is widely recognized within medical device consulting companies & the life science industry for our remediation services & 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.
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® due diligence 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, Regulatory Compliance Associates 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
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.
Among the emerging topics of interest to the life science industry, quality culture, quality metrics, and data integrity are in the spotlight due to changes from the COVID-19 pandemic. Regulatory authorities strive to stay on top of the latest challenges in quality assurance and compliance facing medical device and pharmaceutical firms.
Regulatory Compliance Associates® understands that data integrity is important for keeping and maintaining accurate data to protect your data’s trustworthiness. This ensures everything else built on that data is trustworthy as well. We’ll explore why quality culture and data integrity are important and what permanent changes have occurred in the wake of the pandemic.
It’s essential to understand the ways quality culture is linked to data integrity. Regulators have delineated a clear link between the veracity of data generated by a company and its culture. Future regulatory audits to determine an organization’s health may focus on obtaining information about the company’s quality culture and subsequent data. It’s vital to for companies to acknowledge this relationship so they can identify vulnerabilities, perform necessary risk assessments and remediate risks before an inspection.
An Increased Emphasis on Data Integrity
It’s easier to keep a vigilant eye on data when everyone works from the same locations. However, with more people working from home, maintaining quality culture practices to control data integrity is imperative and challenging. The Food and Drug Administration (FDA) is drawing parallels between compliance with data integrity regulations and an organization’s overall culture.
The FDA wants companies to maintain a quality culture that is integrated throughout the organization. The more developed and established an organization’s quality culture, the more reliable the data.
As a result of the pandemic, more companies are switching from paper-based to electronic systems. This migration to electronic data systems poses certain challenges to any organization.
Companies need to have the necessary resources and technical expertise to make sure the electronic systems maintain data integrity concepts. Organizations must be able to provide proof of their compliance supported by an audit trail of their work.
Auditing Process Changes Resulting from the COVID-19 Pandemic
The auditing process may change in many ways as a result of the pandemic:
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 and create a customized approach depending on your product and your pharma 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 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, from Regulatory Support for New Products to Life Cycle Management, to other services like 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.
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 through the quality compliance process.
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, and we excel in transferring pharma consulting knowledge to your organization.
Regulatory Compliance Associates has a proven remediation services approach to managing FDA Warning Letters, Consent Decrees, Remediation 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 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.
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About Regulatory Compliance Associates
Regulatory 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
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.
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Our Certificate of Registration demonstrates that our Quality Management System meets the requirements of ISO 9001:2015, an internationally recognized standard of quality.
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The International Medical Device Regulation Forum (IMDRF) recently published updated cybersecurity guidance for the medical device industry. The medical device cybersecurity working groups at IMDRF have been busy lately, publishing multiple final documents about medical devices & software as medical device (SaMD).
Regulatory Compliance
IMDRF’s medical device guidance provides steering assumptions for both regulatory compliance & medical device cybersecurity, which are appropriate for sponsors developing medical devices. Further, a primary objective of the guidance is simultaneously increasing patient safety & reducing external threats for providers and HCPs.
Global Harmonization
The guidance begins with harmonization concepts that could affect multiple departments inside a medical device manufacturer. Additionally, key areas for harmonization programs highlighted by the cybersecurity guidance include:
Product design
Risk management activities
Device labelling
Regulatory submission
Information sharing
Post-market activities
Product Life Cycle (PLC)
IMDRF’s cybersecurity guidance continues on with a deeper evaluation of risks associated across the product life cycle. It is recommended for potential vulnerabilities to be considered for any product life cycle stage, especially considering legacy devices that may be vulnerable to strategic risk.
Product Design
Product design considerations include the initial phases of medical device development and continues until the end of support (EOS) once a product is discontinued. The four product design stages the cybersecurity guidance refers to when it comes to total product life cycle:
Development Stage
Support Stage
Limited Stage
End of Support
Development Stage (Stage 1)
The Development Stage occurs during the pre-commercialization phase before a medical device is approved by a regulatory body. This is when medical device manufacturers begin to incorporate security into the product concepts being designed. Design controls are critical in this stage for medical device manufacturers to leverage when considering how to mitigate risks.
Finally, an important deliverable of the Development Stage is product-related security documentation. The documentation is designed to help unfamiliar users to understand how to securely operate the medical device.
Support Stage (Stage 2)
The Support stage is during the initial post-launch phase and may continue for many years. Medical devices in this stage are:
Currently used for providing patient care
Available for purchase on the open market
Contain major software, firmware, or programmable hardware components
Support for software, firmware or components is provided by the medical device manufacturer
Additionally, medical devices in the Support stage should receive full cybersecurity support. This support often includes software patches, software updates, hardware updates, and incremental support the manufacturer considers appropriate.
Limited Support Stage (Stage 3)
Medical device manufacturers continue to provide cybersecurity support during Stage 3. However, as product development transitions to a more current medical device design, different constraints are involved with the transition. Medical devices in Stage 3 often require additional network controls compared to medical devices in Stage 2:
Third-party components or software may be used more frequently than internally developed updates or patches
Cybersecurity best practices integration is often governed by the ease of following support practices outlined in the Stage 2
Medical device manufacturers must explain to users the existing limitations that are now recognized in the devices and services affected
Healthcare providers using the medical device should begin to take more of an active role in unmitigated features of security defense.
End of Support Stage (Stage 4)
Medical devices in Stage 4 are considered more vulnerable than any of the other stages. They may still be in use for providing patient care, but they have been publicly identified as no longer being supported by the medical device manufacturer. Each of these scenarios result in a medical device that cannot be consistently defended against modern cybersecurity dangers.
Critical facets healthcare information technology departments should look for include:
Medical devices that have been declared EOS by the medical device manufacturer
Medical devices that are not actively marketed or sold by the medical device manufacturer
Medical devices that contain software, firmware, or programmable hardware components no longer supported by software developers
Medical devices with known risks to device safety and effectiveness that are unmitigated
Risk Management
Further, the guidance calls for a risk management approach to product lifecycle management featuring:
Security risk analysis
Security risk evaluation
Security risk control
Security risk acceptability
The cybersecurity guidance expands on product design and how security is incorporated and maintained through the product life cycle. This can be accomplished through using risk control and a secure development framework.
Risk mitigation recommendations for medical device manufacturers include:
Security design and controls based on intended use of the medical device
Security risk assessments across the risk management process
Threat modelling to help determine operational risk
Security testing and communication for medical device manufacturers include:
Customer facing product security documentation & communication
Post-market monitoring of cybersecurity vulnerabilities
Identification of vulnerabilities in third party risk management
Vulnerability risk identification based on the device security design, controls, and mitigations
Ensuring availability of security patches & mitigations based on device risk:
Coordinated and clear communication to all affected users
Description related to the vulnerability and its corresponding mitigations
Identification of other mitigation options when a security patch is unavailable
Data Integrity
One of the core principles the guidance stresses is cybersecurity information, data integrity and the importance of information sharing. IMDRF encourages medical device industry stakeholders to implement a proactive pre- and post-market approach to cybersecurity information sharing.
Moreover, timely information can help the industry recognize threats, evaluate associated risks, and react quickly as needed. An increase in industry transparency could directly benefit healthcare providers, medical device users and medical device companies.
Security Updates
An important section of the medical device cybersecurity guidance details stakeholder responsibilities related communications, risk management, and transfer of responsibility. Specifically, it is important that medical device manufacturer communications are comprehensive & identify types of documentation needed and when the medical device user may need it.
Product Security Documentation
Medical device manufacturers should ideally provide PLC documentation about security or support changes early in the Support stage. This helps HCP risk management during both the procurement & deployment of medical devices. Types of life cycle support for product security documentation includes:
Manufacturer disclosure statement for medical device security
Software Bill of Materials (SBOM)
Security test report summaries
Third-party security certifications
Customer security documentation
Product Life Cycle Documentation
Medical device companies should communicate the strategic life cycle milestones to their customers. Further, these interactions would include cybersecurity EOL and EOS dates if available. This helps to support HCPs during both the procurement & installation process.
Additionally, medical device manufacturers should provide this information as far in advance as possible. The goal is at least 2 years in advance to best support healthcare professionals with the following information:
Affected medical devices
Medical device operating system(s)
Version of medical device deployed
Medical device software components
Expected date of medical device service changes
Extent of medical device maintenance after a service change occurs
Additional design controls that help all involves parties
Vulnerability & Patching Information
If a vulnerability is uncovered, medical device companies should provide related vulnerability information. Further, the guidance specifically mentions the importance of both the appropriate mitigation or available software patch. Additionally, the guidance stresses an elevated priority be placed on high-risk vulnerabilities where timely communication is required. This communication is designed to help prevent both patient injury or device interruption.
Finally, the mitigation method and implementation instructions should be provided to the medical device operators. These security updates include both an over-air update or deployment of service personnel to help install the remedy.
Proactive Communications for Third-Party Components
Medical device software and other digital components within a medical device will reach EOL/EOS before the product itself does. In these cases, risk can increase based on the lack of support for these elements. To help compensate for these security risks, the cybersecurity guidance suggests medical device companies should:
Validate the list of third-party components used in medical devices
Track support status updates of third-party components used within their device
Assess the risks that exist when third-party components become unsupported
Communicate new risks and available risk mitigations to healthcare providers
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Developing a crisis management playbook designed for the challenges of the pharmaceutical industry sector is vital to ensuring long term business continuity. Below are a few critical risk management elements you should consider for your team during crisis handling & developing a crisis management playbook.
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