Design Verification, Validation and Testing for Medical Devices 2019

  • 15 Feb 2019
  • Webinar

Description

Topics
  • Applicable design verification and validation requirements
  • Product development process overview
  • Translation of user requirements into design inputs
  • Testing requirements including the pertinent ISO Standards
  • Focusing on critical to customer and quality requirements
  • Role of testing and regulatory requirements
  • Traceability and risk management at all stages
  • Design verification and design validation activity cycles
  • Proof for how design outputs meet functional and operational requirements
  • Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
  • Test requirements to fulfill acceptance criteria for final products
  • Compatibility of the design with components and other accessories
  • How are changes and their effects controlled and documented during the device life cycle?
  • How to withstand regulatory scrutiny
  • Summary
Who should Attend
  • Middle management
  • Senior management
  • Quality Engineers
  • Research & Development
  • Regulatory Affairs Professionals
  • Manufacturing Engineers
  • Device Design Team
  • Quality Assurance & Quality Control Personnel
  • Device Manufacturing Team
  • Device Development Team
  • Start up Company Leaders
  • Verification and/or Validation planning, execution and documentation for devices

Past Events

Important

Please, check "Design Verification, Validation and Testing for Medical Devices" official website for possible changes, before making any traveling arrangements

Event Categories

Business: Innovations, Quality assurance
Health & Medicine: Medical device, Medical technology

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