Are you ready to take advantage of the FDA’s proposed Quality Management System Regulation (QMSR)?
No longer a far-off possibility, harmonization of the FDA’s Quality System Regulation (QSR) with ISO 13485 is well in motion. Will you be in compliance?
Harmonization means changes. It can mean success — if you understand the differences between QSR and ISO 13485, you can adjust your quality management system (QMS) accordingly.
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 QMSR, adjust your QMS and reap the benefits of harmonization, explaining:
- 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 webinar. Click here to learn more or register.
