Why Design Validation is More Than Testing: How do we validate our validation?

The “textbook” approach to design validation is intended to make sure we design the “right” device, i.e., the device meets user needs and intended uses.  But what exactly does that mean and how do we do it?  More importantly, how do we know we did it right?  If we tick the validation checkbox, can we assume our validation is correct? 

Validation usually involves a lot of testing.  But what tests do we do?  What tests do we not do?  When can we use standard tests and when do we have to develop new ones? More importantly, how do we know we’re doing the right tests? If a test is “required” must we do it? In other words, how do we validate our validation?  And how do we defend our validation when FDA criticizes it?

Finally, the “textbook” approach to design validation is very myopic.  What else needs to be validated? human factors plan? reprocessing methods? post-market surveillance system? what else? 

Watch the webinar

MDrues webinar - why validation is more than testing
Using the case study approach, we’ll address these questions and more in an interactive fashion:
  • 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?
  • What else needs to be validated?
  • What are we not required to validate but we should anyway?
  • How do we take a holistic approach to validation?
  • What are the validation challenges for the future, i.e., 3-D printing, etc.?
  • Q&A Session
Who Should Attend?
  • Medical Device Executives
  • Product Development Engineers
  • Product Managers
  • Regulatory Affairs Professionals
  • UX Designers
Register Now  

Hosted by

M.Drues Headshot circle (3)
Presenter: Mike Drues

President, Vascular Sciences

Moderator: Jon Speer

Founder & VP QA/RA, Greenlight Guru


About Vascular Sciences
Vascular Sciences has been conducting seminars specifically geared toward medical device design, development and testing since 1996. These seminars have been requested by companies ranging in size from start-up to fortune 100 companies, the European Patent Office and the FDA Centers for Devices and Radiological Health (CDRH). Visit their website tolearn more.


About Greenlight Guru

Greenlight Guru is the only Medical Device Success Platform (MDSP) for companies to bring new products to market faster while simplifying regulatory compliance and reducing risk. Being the only industry specific, cloud-based software, Greenlight Guru is easier to implement, easier to use and designed to fit all medical device needs to enable innovative, safe and effective, True Quality medical devices. Visit our homepage to learn more.

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