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R&D Workshop: Design History File
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When: Thursday, Dec 1
7:30am - Registration & Breakfast; 8:00 Program
Where: NITA Training Center
1685 38th Street
Suite 200
Boulder, Colorado  80301
United States
Contact: Tracey
(303) 592-4088

Online registration is closed.
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Companies commonly face the challenge of assessing and updating design history files (DHF) as a result of design obsolesce, product updates, transfer of design ownership and changing regulatory requirements. This seminar will provide an overview of DHF requirements, present a framework for DHF gap analysis and remediation, and offer a checklist of critical DHF assessment areas for complex medical devices. Additionally a review will be conducted to take the mystery out of how DHF requirements integrate with a Quality Management System. .

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