Design Verification And Validation

🎤  Alan M. Golden        |  📅  March 07, 2024    |  🕒  60 Minutes

Who Should Attend:  Quality Assurance Departments Quality Control Departments Regulatory Affairs Departments Research and Development Departments Manufacturing Departments Engineering Departments Operations Departments Production and Product Support Personnel Professionals in Design, Development, Marketing or Support of regulated medical devices.

Description:

This webinar focuses on regulatory compliance for medical devices, with a strong emphasis on verification and validation of design inputs. Gain insights into essential regulations, tracing inputs to verification/validation, and utilizing statistical techniques for effective validation.

Inadequate design control can jeopardize FDA approval and CE mark applications for medical devices. Many products face market rejection due to incomplete or improper verification and validation. Our seminar equips participants with fundamental knowledge to navigate design verification and validation concepts, ensuring implementation in their respective roles.

Design input verification and validation are pivotal stages in medical device development, providing tangible proof that the product aligns with its intended design and user needs. Without these critical steps, regulatory agencies can't ascertain a product's safety, efficacy, and adherence to design requirements.

Areas Covered in the Session:

• Overview of design control flow and were verification and validation fit in
• Basic trace from inputs to verification and validation
• Methods of verification and validation of inputs including statistics
• Writing protocols and records
• Discrepancies and deviations
• Trace matrices form inputs to outputs