Our Latest Episode

What does Verification & Validation (V&V) really mean in medical device development, and why is it so important? In this video, we break down the V&V process and the critical role it plays in developing safe, effective, and regulatory-ready medical devices. We’ll explore the difference between verification, "Did we build the device correctly?” and validation, “Did we build the correct device?” We’ll walk through the validation process, from defining user needs and intended use to developing validation requirements, creating test plans, using production-equivalent devices, conducting testing, analyzing results, and documenting objective evidence. We’ll look at how well-planned V&V testing can support FDA submissions, ISO 13485 QMS systems, risk management, and regulatory documentation. Whether you’re a biomedical engineer, medical device developer, startup, or established device company, understanding V&V is essential to proving that your device not only meets its specifications but works safely and effectively for the people who use it.