Webinar | Navigating FDA Compliance: Defining Your QMSR Journey

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Effective February 2, 2026, manufacturers selling devices in the United States must have a Quality Management System (QMS) that complies with ISO 13485 requirements, along with additional changes to address FDA-specific requirements. If you currently comply with the FDA’s Quality System Regulation (QSR) under 21 CFR Part 820 but not ISO 13485:2016, you may have a long journey ahead of you. In this webinar, join MedEnvoy’s regulatory experts as we provide tips on completing this transition and achieving compliance before the deadline.

Join us for this in-depth presentation on February 18th from 10 AM to 11 AM CST.

Speaker:

Daryl Wisdahl Senior Regulatory Affairs Consultant

Biography:

Daryl has more than thirty years of experience in the medical device industry and specializes in Quality Management System (QMS) implementation and compliance, as well as regulatory submissions for medical devices. His quality background includes implementing QMS, conducting supplier audits to FDA QSR, ISO 13485, the In Vitro Diagnostics Directive and Regulation (IVDD and IVDR), the Medical Devices Directive and Regulation (MDD and MDR), and MDSAP. His regulatory background includes over 100 Health Canada submissions and licenses, 15+ FDA 510(k) filings and clearances, 10+ European Technical File submissions, and FDA PMA submissions.

Speaker:

Jasmine Hall Senior Regulatory Affairs Consultant

Biography: