Services: Strategic Consulting-Device

For Medical Device Industry

Quality System Development

Background

PediaVision, the inventor of an objective pediatric vision screener, was in need of a quality system surrounding their medical device. The early-stage company had a business plan in place, a solid IP platform and a distribution plan, but they needed a quality system, regulatory pathway and quality strategy.

Solution

regulatory complianceRegulatory Compliance Associates® (RCA) provided PediaVision with an overview of the RA and QA requirements and helped PediaVision develop a compliant quality management system. As the company transitioned to manufacturing stage, RCA helped PediaVision implement a CAPA program, a management review process and an internal audit plan.

RCA’s Compliance Assurance Assessment process included:

  • Current Good Manufacturing Practice (cGMP)
  • International Organization for Standardization (ISO)
  • Quality Infrastructure
  • Corrective and preventive Action (CAPA)
  • Validation
  • Facility and Maintenance
  • Pre-Approval Inspection (PAI)
  • Data Integrity
  • Start-up Assessments

 

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. 

 

Outsourcing & Staff Augmentation

In this episode of RCA Radio, host Brandon Miller is joined by Erika Porcelli, CEO of Regulatory Compliance Associates® (RCA), to go over outsourcing leadership roles and how companies use staff augmentation to jump-start their project teams.

Listen in as we talk about what outsourced leadership and staff augmentation are by providing brief background and current trends in the industry. Then move on to talk about the process of augmenting your staff, the benefits, and why having a subject matter expert is critical in these types of projects.

 

RCA Outsourcing  & Staff Augmentation Services

Outsourcing has become an increasingly common practice in the life science industry. The quality assurance (QA) and regulatory affairs (RA) functions create extra complexity for large and small life science companies because needs may vary greatly depending on the life cycle of the organization. 

All companies experience staffing support issues whether they are transient and short-lived, chronic and unplanned, or intrinsic to your business model. RCA® has pharmaceutical consultants and medical device consultants that can develop a solution to your specific needs; we can help “right-size” your team when and where you need it most.

Project Management

To be successful in the field of manufacturing, you must have a proper project management plan in place. Not only do project management procedures keep your projects on time and on schedule, but they also ensure your devices’ compliance with stringent national and international regulations. RCA can help you develop an effective plan, and we can even lead these tasks so that you can run more projects at one time more efficiently. Our project management capabilities include:

  • On-site Project Leadership or Project Management Support
  • Design and Implementation of a Project Management Office
  • FDA Workshops
  • Project Assessment, Remediation, and Follow-up
  • Advanced Schedule Optimization and Management
  • Development and Implementation of Compliant Methods
    • Risk Management
    • Issues Resolution and Decision Tracking
    • Change Management
    • Performance Measurement and Tracking
  • Tool Selection for Program Portfolio and Resource Management

Staff Augmentation

Many companies need the assistance of a professional with specific skills and expertise when completing a project but might not have the need or resources to hire this expert as a full-time employee. Instead, you can add professionals to your staff for a short- or long-term project through our staffing support capabilities. RCA’s outsourcing solutions can help you manage even your most complex projects with experts trained in areas such as:

  • Quality Assurance
  • Regulatory Affairs
  • Validation
  • Operations
  • Product Development

Consulting Support

Maybe your company is struggling to complete projects on time, or perhaps you often face challenges associated with product compliance. Whatever your situation, our consultants will work with you to ensure your business’ success with consulting support services. By getting to know more about your business and goals, we’ll tailor our approach to best meet your particular needs.

Project-Based Solution Implementation

When you hit a snag in your project’s development, you need to design and develop the best solution to create a timely, quality finished product. Our quality assurance and regulatory affairs consultants can help you define the specific problem, generate ideas for a potential solution, and implement that solution for the utmost success in your project’s completion.

Cost-Effective Staffing Solutions

Manufacturers face the challenging task of creating top-quality products quickly with minimal personnel and growing compliance regulations to adhere to. With these increasing challenges, it’s no wonder so many local startups and Fortune 100 companies alike choose RCA for their outsourcing, staffing support, and project management services.

 

Our goal is to help you get your projects to completion on time and on budget — all while keeping superior quality at the forefront of your every task. And with a team of more than 500 associates and industry experts with an average of 25 years of experience in the life science industries, we have the extensive resources and expertise needed to meet this goal.

 

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 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

 

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.

 

  • 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 through the 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, and we excel in transferring pharma consulting knowledge to your organization.

 

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

 

Remediation Services 

 

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.

 

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

 

About Regulatory Compliance Associates

 

pharmaceutical consultantsRegulatory 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. 

 

Manufacturing Automation for Medical Devices

Background

A medical device client designed and built manufacturing automation to assemble and weld medical-grade check valves.

The automation component of the equipment consisted of a PLC, an HMI, a vision system, and an ultrasonic welder. An ISO audit found that the software driving the client’s automated assembly equipment had not been validated. Additionally, new, urgently needed equipment had recently been built and needed validation, but the client did not have sufficient software validation expertise available in-house.

Approach

RCA provided software validation as an integral part of equipment validation. A risk assessment was performed to determine which user and functional requirements represented the greatest risk to product quality and patient safety (per GAMP 5). The manufacturing automation functions that presented the greatest risk received the highest level of testing to ensure that the automation equipment consistently assembled components to meet critical product specification requirements. This approach provided a robust validation and reduced the overall validation project timeline.

Challenge

Regulatory Compliance Associates® Inc. (RCA) was contracted to develop validation documentation and provide validation services to ensure software was adequately validated and the valve assembly machine was prepared for production. The entire process required completion within an aggressive time frame.

Result

The validation was completed within the aggressive time frame, and the validation effort focused on equipment functionality that represented the highest risk to product quality and patient safety. The client received a defendable validation and the new equipment was available for production by the project target date.

 

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. 

 

Biocompatibility

In this episode of RCA Radio, host Brandon Miller is joined by Dr. Matthew Jorgensen and Dr. Helin Räägel from Nelson Labs. Click now to listen to RCA’s biocompatibility podcast as Matt and Helin help educate our listers about the world of pre-clinical testing/biocompatibility for medical devices.

Matt a board-certified toxicologist with a Ph.D. in chemistry and is Nelson Laboratory’s Chemistry and Materials Scientist and Helin is Nelson Labs Senior Biocompatibility Expert with a Ph.D. in cell biology.  We cover the basic background of pre-clinical testing, explore the new things happening in the field, go over some best practices for testing, and advice on picking a testing lab.

 

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. 

 

 

Regulatory Due Diligence

Background

Wanting to purchase a medical enterprise, a private equity firm contacted Regulatory Compliance Associates® to perform a regulatory due diligence analysis of a target company within an extremely tight time-line.

The due diligence process included multiple operations in North America, Europe, and East Asia. The nature of the target enterprise presented potential for risks within the operational structures and disciplines on multiple levels.

Challenge

With this type of company, the risks could be technical, operational, or legal, and arise from a range of regulated areas. This added to the due diligence process complexity of ensuring all relevant areas were identified and evaluated. In addition, the private equity firm asked RCA to assess expansion capabilities and develop an understanding of any structural limitations that could affect the financial transaction or provide leverage during the deal negotiations.

Approach

RCA immediately identified that a cross-functional team of technical and regulatory subject matter experts would be needed. Within 24 hours, technical functions were matched with skilled resources to study the regulatory, operational, and quality aspects of the target enterprise.

Working with the client and the material in the data room, this team quickly identified the critical risk areas. Risks were prioritized in the order of assessing the different operations. A comprehensive checklist was prepared to support the facility visits and the corporate headquarters assessment.

With preparation complete and time-limited, the RCA team was given the go-ahead to initiate the on-site corporate and facilities visits. Across a total of eight days, the team successfully completed nineteen facility visits and a corporate office assessment.

The private equity firm was provided with timely updates that they were able to integrate into the ongoing negotiations.

All findings and recommendations were compiled into a final report, resulting in a successful negotiation. Providing dependable and consistent information on a daily basis, RCA delivered recommendations that contributed to a successful negotiation.

Result

RCA leveraged our personnel with extensive subject matter expertise to successfully provide a comprehensive mapping of the technical, regulatory, quality, and industry findings. The final regulatory procedures report for the equity firm was utilized in negotiating the sale. Expert counsel was provided in a number of areas, including to quantify the range of potential health and safety liabilities.

Additionally, risk mapping and assessment of remediation costs enabled the client to successfully negotiate the purchase price of the medical enterprise.

 

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. 

 

Product Development Process

Background

regulatory complianceA global manufacturer of pharmaceutical and medical devices needed to better integrate key risk indicators throughout the product lifecycle. FDA had noted issues with risk management among a list of FDA 483 observations. Additionally, standardization of the product development process (PDP) across multiple businesses and global locations was needed.

Challenge

RCA was requested to write new PDP procedures that would apply to both drug and device developments. These risks analysis procedures needed to be comprehensive yet flexible to be useful for design changes, line extensions, and OEM manufacturing.

Approach

Regulatory Compliance Associates® Inc. (RCA) provided medical device consultants who were experts in product development and quality system regulations. After identifying key risk indicators, the risk management framework included a portfolio of over ten new procedures and thirty templates. Operational risk & financial risk training was provided to client locations in the US and Europe.

Result

The new product development process was implemented and risk control was integrated in the following ways:

  • Risk Management Planning is a part of Design & Development Planning
  • Risk Analysis is an input to Verification and Validation test planning
  • Risk Analysis via Process FMEA is required for OEM business
  • Risk Reports and Risk Benefit Analysis are inputs to Final Design Review
  • Risk Analysis and Reports reviewed periodically based on internally generated data and data received from customers (i.e., complaints)

 

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.