FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485
Devicemakers who followed to the letter the FDA’s QSR “bible” – 21 CFR 820 – over the past two-plus decades found manufacturing success. Now that the agency is more closely aligning QSR with the ISO 13485 international standard, you need to find your footing on newly shaky ground. Fortunately, FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485 shows you how to do just that.
This report answers the key questions that will enable you to prepare for harmonization: Where does ISO 13485 differ from the QSR and how does the FDA intend to close those gaps? When will this happen? How can you get involved in this effort and make sure your interests are represented?
Take advantage of upcoming opportunities with FDA’s New Quality System Regulation. You’ll know when and how to take strategic steps to assess your current quality systems, apply for ISO 13485 certification and submit comments on/contribute to the FDA’s proposed rule.
Management report takeaways:
- FDA’s harmonization efforts — understanding the past to prepare for the future
- The agency’s next steps, including issuing a proposed rule, preparing a new compliance program and updating inspection procedures
- Existing tools devicemakers can use to prepare, including becoming familiar with the Medical Device Single-Audit Program (MDSAP) and the international risk management standard, ISO 14971
- The procedures for release of a proposed rule and how to submit comments on it
- Comparison of the key provisions of the QSR with those of ISO 13485
Don’t get caught off guard by QSR harmonization. Prepare now with FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485.
About the Contributor
Julie Larsen is a principal consultant and director of inspection readiness services at BioTeknica, a quality and regulatory compliance and engineering consulting firm in Coral Gables, Florida. She is a Certified Quality Manager (CQM), a Medical Technologist (MTASCP) and has more than 30 years’ experience in quality assurance and compliance in the medical device and pharmaceutical industries.
Who Will Benefit
- Regulatory/compliance staff
- Quality systems managers
- Operations managers
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