FAQ

ISO I3485 & 21 CFR 820 Compliance Q&A

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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.

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Why Is ISO 13485 So Important?

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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.

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Compatibility With Europe

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

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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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