Best Practices For Medical Device Change Management: Don't Use FDA As An Excuse To Hold You Back! 

Imagine this scenario: FDA knocks on your door. They say you changed your medical device but did not tell them.

What would you do?

Unlike in the drug world, device companies make changes to existing medical devices all the time.

Sometimes they tell FDA, other times they don’t. And sometimes they get in trouble for making the wrong decision!

So how do you decide when to handle the change internally (via letter-to-file) vs. notifying FDA with a special 510k or PMA supplement?

Despite FDA issuing several guidance's, the choice isn’t always clear.

In this free 90 minute presentationMichael Drues, Ph.D., President of Vascular Sciences, you will teach you how to make improvements to your devices while at the same time avoiding problems with FDA and liability nightmares in the future.

Most importantly, you will learn how to be prepared when the knock comes to your door!

Watch the webinar

Specifically, you will learn:
      • When to use letter-to-file vs. notifying FDA with a special 510k or PMA supplement
      • Does it matter what kind of change you make? (hint: your answer to this question is not nearly as important as your ability to defend it!)
      • How will change management decisions influence your product liability?
      • How to create a LTF that will pass muster at FDA while at the same time not cause product liability nightmares
      • Why imposing design limitations on R&D engineers is not a good way to handle change 
      • Why how you handle change is a business decision not just a regulatory one
      • And much more...

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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