This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.
This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.
Why Should You Attend:
Software problems are now the third-leading cause for recalls of medical devices. Most recalls are because of incorrect verification and validation for safety. Most of the knowledge on how to do a comprehensive V&V is not widely understood. Software design is a complex set of interactions within the device, with the connecting devices, and with users of the device. Usually multiple factors affect the device performance. Therefore right validation is the key to prevent device recalls.This 90-minute presentation will cover the FDA Quality System Requirements for software used in medical devices. The presenter will review FDA guidelines on software verification and validation and discuss methods to verify and validate even complex software.
Learning Objectives:
- Participants will learn
- Why software is too complex to verify?
- The way to validate even complex software.
- The FDA requirements for Verification and validation.
Areas Covered in the Seminar:
- FDA Quality System Requirements for software.
- FDA guidelines on Software Verification and Validation.
- Smart software verification methods.
- How to design smart validation tests.
- How to conduct Black box testing and white box testing to perform thorough validation.
- How to conduct diabolic tests and wicked tests to avoid product recalls.
Who Will Benefit:
- Software developers and managers
- Internal auditors
- Quality Assurance personnel and management
- Software Quality personnel
- Software Test personnel
- Business managers responsible for system compliance
- Regulatory affairs personnel and management
- IT managers and system administrators
- Software Validation engineers
- Regulatory affairs
- Documentation department
Course Provider
Dev Raheja,
