2014 - Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR

DESCRIPTION
Device manufacturers are required to establish and maintain a quality management system, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements including DHF, DHR and DMR. This presentation is further intended to help you establish and maintain adequate design control procedures for all classes of medical devices including IVDs.
Areas To Be Covered in this Webinar:
Federal Statutes and Regulations Governing Medical Devices in the US
Introduction and Definitions
Design and Development Planning
Design Input
Design Output
Design Review
Design Verification And Validation including Software Validation
Design Transfer
Design Changes
Design History File (DHF)
Device History Record (DHR)
Device Master Record (DMR)
Enforcement Actions
Speaker’s PASS-IT recommendations/suggestions
Who will benefit:
R&D Scientists, Engineers, Managers, and Directors
Regulatory Affairs
Quality Professionals
Product Development Professionals
CROs
Consultants
Senior Management
Contractors and Subcontractors
Anyone interested in the subject
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance