ARTICLE SUMMARY:
FDA inspections are nobody’s idea of a good time. However, proper planning is crucial not only for ensuring baseline compliance, but also for establishing an effective corporate culture and building long-term company value. In this edition of Consultants Corner, we spotlight advice from Jamie Harris and Nancy Lincé, who discussed the issue onstage last month at the MedTech Strategist Innovation Summit in Dublin.
Welcome to Consultants Corner, where we check in with independent experts about questions they are answering or challenges they are solving for clients on the front lines of medtech regulatory, reimbursement, and market access.
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Jamie Harris (pictured left), senior manager of regulatory affairs for ICON, has more than 25 years of experience in the medtech and biotech industries, including with Genentech, Intel, J&J, and Medtronic. She specializes in change management, interfacing with global regulatory agencies, and supporting internal and external audit programs. Nancy Lincé (right), president and CEO of Lincé Consulting, has more than 30 years of experience in regulatory, clinical, and quality affairs for various medical technologies including innovative device, combination, and drug delivery products. Her firm offers services to clients ranging from start-ups to large corporations. The two discussed “FDA Inspections: Getting Prepped and Avoiding Pitfalls” on an April 18 panel at the MedTech Strategist Innovation Summit Dublin 2024. |
Question: When Is FDA Coming?
FDA device inspection readiness requires both thoughtful planning and quick thinking. On the one hand, building an effective and compliant quality management system takes meaningful investments and time. On the other hand, you had better have the right people ready to respond when FDA knocks on your door. Sometimes the agency will do so without much or any notice.
