Special Considerations during Medical Device Design: Dos and Don`ts 2014

  • 26 Nov 2014
  • Webinar

Description

Topics
  • Device Design Concept
  • Statutes and Regulations
  • Design and Development Planning
  • Definitions
  • Design Control System Components
  • Key Considerations
  • Design Input and Design Output
  • Design Control Sub-Systems
  • Design V and/or V
  • Design Review
  • Design History File (DHF), Device History Record (DHR) and Device Master Record (DMR)
  • Design Transfer and Design Changes
  • How to Prepare for FDA inspection for Design Control
  • Common Mistakes and How to Avoid
  • Speaker’s Recommendation and Suggestions on PASS-IT Solutions
  • Best Practices based on Actual Cases
Who should Attend
  • Quality professionals (associates, specialists, managers, directors or VPs)
  • Regulatory affairs (associates, specialists, managers, directors or VPs)
  • Complaint and risk management personnel
  • R&D (engineers, scientists, managers, directors or VPs)
  • Contractors/subcontractors
  • Consultants
  • VPs
  • CEOs
  • Other interested parties
  • Clinical affairs (associates, specialists, managers, directors or VPs)

Past Events

Important

Please, check "Special Considerations during Medical Device Design: Dos and Don`ts" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Medical device

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