FDA’s New Quality Management System Regulation: What the Proposed Harmonization with ISO 13485 Means for Devicemakers
Ready for your share of a $533 million cost savings? And quicker patient access to your newly developed medical devices? The FDA estimates both will be true for devicemakers that comply with its proposed Quality Management System Regulation (QMSR) when it is finalized.
No longer a far-off possibility, harmonization of the FDA’s Quality System Regulation (QSR) with ISO 13485 is well in motion. This means all of the above for you — cost savings, faster patient access — if you understand the differences between the two methods, can adjust your quality management system (QMS) accordingly and participate during the QMSR comment period.
That’s where Kristen Grumet comes in. This senior vice president of regulatory compliance at Greenleaf Health also has nine years’ experience as an FDA field investigator specializing in medical devices. She will ensure you understand the proposed rule so you can comment on it by the May 24 deadline, adjust your QMS and reap the benefits of harmonization.
- The commonalities and differences between ISO 13485:2016 and the FDA’s proposed QMSR, including:
- The difference between being able to demonstrate competence of personnel vs. providing evidence of training
- The expectations for risk management and a risk-based approach throughout the QMS vs. the use of risk analysis during design controls
- The commonalities and differences between how the quality system requirements are enforced by the FDA vs. notified body auditors (e.g., auditing styles and potential regulatory repercussions of noncompliance)
- The history and driving force behind harmonization: why the FDA is changing the QSR now after more than 20 years of successful implementation
- The advantages and potential disadvantages of harmonization, such as how the satellite regulations of Part 803 (MDR Reporting) and Part 806 (Corrections and Removals) fit in under ISO 13485:2016 and what happens to the FDA’s Quality Systems Inspection Technique (QSIT) program
- What to expect during the transition from the current QSR to the new QMSR, including how much time you will have to adopt the new requirements and how the FDA will enforce them during the transition period
Get ready for the new QMSR — and all its possibilities for your devices — with this presentation.
Meet Your Presenter
Kristen Grumet is senior vice president of regulatory compliance at Greenleaf Health and an expert in the field of medical device compliance. She has nine years of experience as an FDA field investigator specializing in medical devices and more than 20 years of quality systems compliance management and consulting experience for the industry. As a member of the FDA’s Design Control Inspection Strategy (DCIS) Team and the FDA’s Pacific Region Design Control Training Cadre, she contributed to the development and implementation of the DCIS questionnaire for medical device inspections and trained companies in the use of the questionnaire. At the FDA, she was a Phase II-certified performance auditor in the area of medical devices and has the distinction of being part of the first cadre of certified medical device investigators in FDA history, conducting numerous inspections of European medical device facilities during her six-year tenure with the FDA foreign inspection cadre.
Who Will Benefit
- Quality professionals (All Levels)
- R&D professionals involved with design controls for medical devices
- Internal auditors
- All employees with quality system compliance responsibilities
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April 27, 2022