Verification and Validation (V&V) of Software in the Medical Devices

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.

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 managem