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Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and/or maintaining a robust and comprehensive global Quality Management System (QMS).

About RCA
Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the pharmaceutical, biologic, sterile compounding, biotechnology, and medical device industries for resolution of compliance and regulatory challenges.

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Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Correspondence Between ISO 13485:2016 and 21 CFR Part 820 QMS Requirements

Download our Free ISO Comparison Matrix

Understanding the similarities and differences between ISO 13485:2016 and CFR 21 Part 820 is a key step toward creating and / or maintaining a robust and comprehensive global Quality Management System (QMS).

Our Comparison Matrix provides a summary overview of the regulation and the standard in a simple and easy-to-use table format.

What is your QMS and how does it stand up to the International Standard and applicable regulatory requirements? Who determines the processes, sequences, and interactions of these ISO 13485:2016 processes? View our chart and compare how close—or far—you are to meeting QMS regulations for your device.

About RCA

ISO 13485:2016Regulatory Compliance Associates® Inc. (RCA) provides worldwide services to the following industries for resolution of compliance and regulatory 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-and globally-regulated companies.

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

  • Founded in 2000
  • Headquartered in Southeastern Wisconsin, with offices in West Central Florida; North Central Colorado; and Central Eastern Europe
  • Expertise backed by over 500 industry subject matter experts

Mission Statement

Regulatory Compliance Associates® Inc. is driven to improve the overall health and well-being of patients around the world by providing expert consulting services tailored to the business needs of its clients.

The RCA Global Difference

  • We are the consultants who know how to get things done with quality results, on time and on budget.
  • Our expert resources are a strategic blend of top industry veterans, experienced specialists, and stellar consultants to support any project need.
  • Our management leaders each have two to three decades in FDA-regulated industries.

We have walked the walk.

  • Our approach is differentiated to meet your specific needs.
  • We can provide excellent references, case studies, and testimonials.
  • Our strategy to execution is priced appropriately.

Why Choose RCA

  • RCA is widely recognized within the life science industry and global regulatory agencies for its ability to help companies successfully resolve complex regulatory challenges.
  • By mining regulatory intelligence, RCA continuously evaluates FDA’s current thinking and leverages thought leadership networks to advocate for our clients.
  • We know a quality or compliance crisis can significantly impact your business. We have the experience to manage them.
  • We have the know-how and proven approach to navigate warning letters, consent decrees, and other situations.
  • We know how to partner with your executive, legal, and communication teams.
  • We support management to assist with the growing and changing concerns.
  • We help navigate the storm and manage the impact to your business.

Interested in Learning More?

Contact Us

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