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Note: This publication will be available in PDF format by July 20, 2020.
Are you ready for the major changes coming to medical device regulations both in the U.S. and abroad? Do you understand the relationship between ISO 13485 and 21 CFR 820? And the relationship between ISO 13485 and the EU-MDR requirements?
ISO 13495 has been reconfirmed for another five years and the FDA has announced its intention to replace 21 CFR 820 with the principles of ISO 13485. And in Europe, regulators are working to add the same principles into the new EU-MDR, which will go into effect in May 2021.
Master the interrelationship between these initiatives and the future direction of quality management system (QMS) requirements for your device to ensure compliance.
Evolving Quality Management Regulations: A Devicemaker’s Guide will cover how the FDA’s quality system inspection technique will change and the inspectional authority the FDA will retain. It will discuss how EU member nations will develop their own version of ISO 13485. And it will explain how the wide variety of other ISO standards impact quality systems.
Management Report Takeaways:
- The status of FDA’s adoption of ISO 13485 in place of 21 CFR 820
- The relationship between ISO 13485 and 21 CFR 820
- The relationship between ISO 13485 and the EU-MDR requirements
- How ISO 13485 is used in MDSAP
Understand the changing landscape of ISO medical device developments to develop or update your QMS. Order your copy today.
Who Will Benefit
- Quality systems
- Quality management systems
- Regulatory compliance
- Regulatory affairs
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ISBN-13:
978-1-60430-141-0
Publication date:
July 20, 2020
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