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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 webinar, Joanne Rupprecht, an attorney, regulatory affairs professional, and educator, will outline 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 FDA’s 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, a seasoned leader in regulatory affairs, federal agency/life sciences law, and higher education, boasts 35+ years in healthcare product development across academia and industry. Proficient in domestic (FDA) and international regulatory affairs, quality systems, and CAR T Cell/stem cell therapies, Jo honed skills at the University of Illinois, University of Chicago, Abbott Labs, and earned a Juris Doctor at Denver Sturm College of Law.
With Seton Hall's Life Sciences Compliance Certification, U.S. and Global RAC, ACRP-CP, and CCEP credentials, Jo crafts programs and has written for RAPS. She teaches Biomedical Entrepreneurship and The Regulatory Environment at the University of Colorado, Denver, and serves BESST Program. Bridging science, business, and law, Jo aids healthcare pioneers in intricate regulatory landscapes, adeptly evaluating business risks, policies, and governmental influences to ensure compliant operations.