Understanding FDA Design Verification and Validation Requirements for Medical Devices

Understanding FDA Design Verification and Validation Requirements for Medical Devices is a webinar that covers topics such as:

  • Applicable design verification and validation requirements for your globally distributed medical devices
  • Product development process overview for design control management in the medical device industry
  • Translation of user requirements into design inputs and role of testing and regulatory requirements
  • Testing requirements including the pertinent ISO guidelines
  • Design verification and design validation activity cycles
  • Fulfilling critical to customer and critical to quality requirements
  • Design outputs and documentation in DMR (Device Master Records) and DHR (Device History Records)
  • Traceability and risk management at all stages
  • Compatibility of the design with components and other accessories including software, packaging and labelling management
  • Proof for how design outputs meet functional and operational requirements of your device
  • Design reviews at major decision points to withstand regulatory scrutiny
  • Criteria for establishing test requirements to fulfil acceptance criteria for final products after validation and into the manufacturing cycle
  • Key concepts for translating your device customer requirements into design inputs, outputs
  • How are changes and their effects controlled and documented during the device life cycle?

Understanding FDA Design Verification and Validation Requirements for Medical Devices is intended for:

  • QC/QA Personnel
  • R & D , Quality and Manufacturing Engineers
  • Regulatory Professionals
  • Test Engineers
  • Engineering managers and personnel

Future Events

Understanding FDA Design Verification and Validation Requirements for Medical Devices 2020

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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