Understanding FDA Design Verification and Validation Requirements for Medical Devices 2019
12 Feb 2019
Webinar
Description
Topics
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?
Who should Attend
QC/QA Personnel
R & D , Quality and Manufacturing Engineers
Regulatory Professionals
Test Engineers
Engineering managers and personnel
Past Events
Understanding FDA Design Verification and Validation Requirements for Medical Devices 2019 - 12 Feb 2019, Webinar (76255)
Important
Please, check "Understanding FDA Design Verification and Validation Requirements for Medical Devices" official website for possible changes, before making any traveling arrangements
