ISO I3485 & 21 CFR 820 Compliance Q&A

21 CFR Part 820 – ISO 13485 Harmonization
What's Included:
  • Learn key points of similarities & differences in ISO 13485 and 21 CFR 820
  • Learn how MasterControl can help you address these regulations and be compliant
  • Get answers to questions you may have about ISO 13485 and 21 CFR 820
About This Asset

Learn in this Q&A what the similarities and differences are in ISO 13485 and 21 CFR 820. Also learn what MasterControl’s connection is to these 2 regulations and how we can help you in compliance.

Why Is ISO 13485 So Important?


Better Alignment With the FDA

ISO 13485 compliance helps ensure that companies will meet the FDA's requirements for 21 CFR Part 820 for quality system regulations.


Compatibility With Europe

Compliance with ISO 13485 is often seen as the first step in complying with European regulatory standards.


Supports Quality Management

ISO 13485 helps companies maintain efficient and holistic quality management processes and reflects a strong commitment to continuous improvement.

Put your company in the fast lane for ISO 13485 compliance today.

ISO 13485:2016 has quickly become the global standard for medical device quality requirements. A comprehensive ISO 13485 overview will help your company meet the standard faster and more cost effectively.

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