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-FREE ON-DEMAND WEBINAR-

BEST PRACTICES FOR MEDICAL DEVICE CHANGE MANAGEMENT: DON'T USE FDA AS AN EXCUSE TO HOLD YOU BACK! 

Watch the Free Webinar

 

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!

 

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...

*Note: Limited live seats available.

 

About the Presenter:

Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense.

Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

Dr. Drues is an internationally recognized expert and featured keynote speaker on cutting-edge medical technologies and regulatory affairs. He conducts seminars and short-courses for medical device, pharmaceutical and biotechnology companies, the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the US Centers for Medicare and Medicare Services (CMS) and other regulatory and governmental agencies around the world.

Finally, as an Adjunct Professor of Medicine, Biomedical Engineering & Biotechnology, Dr. Drues teaches graduate courses in Regulatory Affairs & Clinical Trials, Clinical Trial Design, Medical Device Regulatory Affairs & Product Development, Combination Products, Pathophysiology, Medical Technology & Biotechnology at several universities & medical schools onground & on-line


Presenter

 michael_drues

Michael Drues, Ph.D.
President
Vascular Sciences

Moderator

 jon-round-new

Jon Speer
Founder & VP QA/RA
Greenlight Guru

greenight.guru

About greenlight guru

Greenlight Guru is the only Quality Management Software built exclusively for the unquie needs of medical device companies, allowing you to bring safer devices to market faster while reducing risk and ensuring compliance. Visit our home page to learn more.


 

Vascular-Sciences-logo.png
About Vascular Sciences

Valscular Sciences is a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. For additional information, contact Dr. Drues at (508) 887-9486, e-mail mdrues@vascularsci.com or via LinkedIn.


 

 

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