Understanding FDA Design Verification and Validation Requirements for Medical Devices 2019

February 12, 2019
Webinar

Understanding FDA Design Verification and Validation Requirements for Medical Devices 2019 will be held on February 12, 2019.

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
179 US Dollar

Important

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

Prices are for evaluation only.

Find Similar Events by Category

People interested in this event are also interested in:

Control 2019
May 7-10, 2019
Stuttgart, Germany
Warranty Chain Management Conference (WCM 2019)
March 12-14, 2019
Orlando, United States
ASQ 2019 World Conference on Quality and Improvement
May 20-22, 2019
Fort Worth, United States