Why Design Validation is More Than Testing: How to validate your validation

Which testing should/shouldn't be done during design validation? How do you know you're doing the right tests? Watch this video to learn how to validate your testing decisions for medical devices. In this video, Michael Drues, Ph.D., president of quality and regulatory consulting firm Vascular Sciences, presents on this topic using an interactive case study approach to dive into design validation of medical devices. You'll learn the answers to many key, commonly asked questions from manufacturers, including: • What are we required to validate and how/when do we do it? • How do we validate our validation? • How do we defend our validation when FDA questions it? • What are the consequences if our validation is wrong? • If we change our device, when and how do we revalidate? • When can we use standard tests and when do we have to develop new ones? • What are the validation challenges for the future? This presentation originally aired during the Greenlight Guru True Quality Virtual Summit, the first and only of its kind with over 30 of the top medical device experts from around the world who presented on top, trending topics segmented into three main focus tracks: 1) GO Track - Covering everything you need to know to get new devices to market with less risk 2) GROW Track - Covering proven best practices for advancing the success of your devices already on the market 3) COVID-19 Track - Covering practical insights into managing and leading medical device companies and teams during the pandemic The video you’re watching now is from our GO Track. If you’d like to watch more related videos, browse through the full list of free replays from this track of the True Quality Virtual Summit event: https://www.youtube.com/playlist?list=PLkchw-at8PkNdJqyjakLVnTU8rUJX1qPa Plus, download the slides from this presentation for free here: https://www.slideshare.net/greenlightguru/why-design-validation-is-more-than-testing-how-do-we-validate-our-validation Are you looking for a QMS solution to help you bring safer medical devices to market faster with less risk? Take a quick tour of Greenlight Guru's Medical Device QMS software: https://www.greenlight.guru/quality-management-software Like this video? SUBSCRIBE to our channel for more valuable videos on all things medical device! https://www.youtube.com/c/greenlightguru?sub_confirmation=1 #TrueQualityVirtualSummit #MedicalDevice #DesignValidation