Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR 2015

  • 12 May 2015
  • Webinar

Description

Topics
  • Introduction and Definitions
  • Federal Statutes and Regulations Governing Medical Devices in the US
  • Design Input
  • Design and Development Planning
  • Design Review
  • Design Output
  • Design Transfer
  • Design Verification And Validation including Software Validation
  • Design History File (DHF)
  • Design Changes
  • Device Master Record (DMR)
  • Device History Record (DHR)
  • Enforcement Actions
Who should Attend
  • Regulatory Affairs
  • R&D Scientists, Engineers, Managers, and Directors
  • Product Development Professionals
  • Quality Professionals
  • Consultants
  • CROs
  • Contractors and Subcontractors
  • Senior Management

Past Events

Important

Please, check "Implementing an FDA-Compliant Medical Device Design Control Including DHF, DHR, and DMR" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device

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