Design Verification, Validation and Testing for Medical Devices 2019 is a webinar that covers topics such as:
- 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
Design Verification, Validation and Testing for Medical Devices 2019 is intended for:
- 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