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FDA’s proposed Quality Management System Regulation and the new role of ISO 13485:2016
The variety of quality and safety standards, as well as regulatory requirements, that medical device manufacturers must adhere to can be overwhelming, especially if operations are international as well as domestic. However, there are ways to prepare for and conduct an audit that will keep you from being overwhelmed and produce positive results.
ISO 13485 is one of the many International Organization for Standardization (ISO) standards and it is specific to the expectations and requirements for a compliant medical device quality management system in the medical device industry.
In this on-demand webinar, Attorney, Regulatory Affairs Professional and Educator, Joanne Rupprecht, outlines the basic requirements of the ISO 13485 standard and its new role in relation to 21 CFR part 820, the Quality System Regulation (QSR), in light of the U.S. food and drug administration's (FDA) recently proposed amendments, resulting in the new Quality Management System Regulation (QMSR).
Key takeaways:
- Understanding the quality standards of ISO 13485 and the requirements of 21 CFR Part 820, Quality System Regulation (QSR)
- Defining the current relationship between 21 CFR Part 820, the Quality System Regulation (QSR), and ISO 13485 in the U.S.
- Moving forward with the Quality Management System Regulation (QMSR)
- The new importance of ISO 13485 certification
- Best practice tips
- ISO 13485 audit dos and don'ts
Joanne Rupprecht is a seasoned leader in regulatory affairs, federal agency/life sciences law and higher education, with over 35 years' experience in healthcare product development across academia and industry.
Joanne teaches Biomedical Entrepreneurship and The Regulatory Environment at the University of Colorado, Denver and serves BESST Program.
Bridging science, business and law, she aids healthcare pioneers in intricate regulatory landscapes, adeptly evaluating business risks, policies and governmental influences to ensure compliant operations.