Navigating FDA’s Proposed Quality Management System Regulation
Are your quality systems ready for the FDA’s approaching Quality Management System Regulation (QMSR)? Its recently proposed QMSR contains clues for how to adjust your quality systems now so you remain compliant — if you know how to put it to use.
Fortunately, Navigating FDA’s Proposed Quality Management System Regulation is your QMSR lifeline.
It outlines the proposed changes to devicemakers’ quality systems requirements, explains what they mean, interprets the effect they’ll have on your operations and clarifies what actions you must take to comply.
Soon knowing and adhering to the FDA’s Quality Systems Regulation (QSR) will be a thing of the past. To take advantage of upcoming opportunities, you must adjust now.
While some alterations from the agency’s QSR (21 CFR 820) to its proposed QMSR are minor, others are substantial. Are you sure you can tell the difference? Are you certain you’ll understand the impact these changes will have on your processes and your business?
This report provides answers so you can stay compliant, providing clarity and practical advice you can put to use right away.
Management Report Takeaways:
- History of the FDA’s harmonization efforts … with an eye on what’s to come
- How the key provisions of the QSR compare with those of ISO 13485
- What to know about the agency’s next steps: finalizing the proposed rule, preparing a new compliance program and updating inspection procedures
- Must-see feedback gathered from public meetings and comments
- New definitions of terms
- How QMSR will impact other device regulations, including those for unique device identifiers, device tracking, medical device reporting, and corrections and removals
You must prepare your quality management systems for the forthcoming QMSR. Make it easier on yourself by starting today. Make it practically effortless with Navigating FDA’s Proposed Quality Management System Regulation.
About the Contributor
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 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, Ms. Grumet contributed to the development and implementation of the DCIS questionnaire for medical device inspections and trained companies in the use of the questionnaire.
Who Will Benefit
- Regulatory/compliance staff
- Quality systems managers
- Operations managers
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