Understanding FDA Design Verification and Validation Requirements for Medical Devices 2019 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 2019 is intended for:
- QC/QA Personnel
- R & D , Quality and Manufacturing Engineers
- Regulatory Professionals
- Test Engineers
- Engineering managers and personnel
