Medical Device Compliance Assessments
As regulations become more plentiful and stringent, medical device companies face increased issues surrounding compliance. Conducting compliance assessments can help your organization maintain FDA quality standards and enjoy more efficient production. At Regulatory Compliance Associates®, we offer an array of assessment services to help you stay within regulatory guidelines and deliver the best products to your end users.
Regulatory Compliance Associates® Inc. knows how quality and compliance crises can significantly impact your business—and we have the experience to manage them. Our areas of expertise include identifying and assessing any deficiencies to help determine the best approach and solutions.
We’ll work with you to navigate a variety of areas, such as:
- Quality Infrastructure
- Facility and Maintenance
FDA 21 CFR 820 Compliance
All medical device companies in the U.S. are required to adhere to FDA standards. Specifically, FDA 21 CFR part 820 — also known as the Quality System Regulation — outlines current good manufacturing practice (cGMP). This regulation sets the standard for the methods and facilities you use to manufacture products and handle design, manufacturing, labeling, packaging, storage and other factors regarding your medical devices.
Because the Quality System Regulation outlines such a broad array of requirements, it can be challenging for medical device companies to maintain compliance assessment metrics. Regulatory Compliance Associates® takes the stress out of regulatory compliance with our range of assessment services. You can sit back and focus on your business operations while we identify any challenges in maintaining compliance. We’ll then work with you to thoroughly prepare your metrics and documentation for an FDA inspection.
Mergers and Acquisitions / Due Diligence
When a life science company considers a merger or acquisition, it is easy to think of the deal’s risk as a potential conflict with the FDA or its equivalent in other countries. The Regulatory Compliance Associates® due diligence team often analyzes a FDA 483, Warning Letter, notified body finding, and/or product recall. But more often, the real reasons a deal doesn’t deliver value are strategic, cultural, or technical. It’s these value-destroying areas that need to be explored during due diligence.
Regulatory Compliance Associates® leverages its global experience with acquisitions and divestitures to navigate the gray areas of due diligence and help eliminate uncertainties often inherent in a complex deal. These include:
- Regulatory Due Diligence
- Quality Due Diligence
- Facility / Equipment Assessment
- Personnel Assessment
- Risk Identification and Mitigation Planning
- Post-merger Integration
Additional services related to assessments include:
- 21 CFR Part 11 / Annex 11 Assessment
- 21 CFR Part 820 Assessment
- ISO 13485 Assessment
- ISO 9001 Assessment
Regulatory Compliance Associates® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:
- Life Sciences
- Biologic & Biotechnology
- Sterile compounding
- Medical device
- Lab Testing
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.
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