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Medical Device Vigilance/Monitoring

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Robin N. Stephens

Contents include Vigilance; Classification and Conformity; Recall Policy and Procedures; Vigilance Problems; Operating and MDV/MDR System; Post Marketing Surveillance; User Responsibilities; Device Design; Product Liability; Government Reporting Systems; Product Tracking. This book will be of particular interest to Managers and Supervisors in Regulatory Affairs, Scientific Affairs, Quality Assurance, Field Assurance, and Technical Services as both a guide for strategic planning and reference for day-to-day activities.

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