FREE ON-DEMAND WEBINAR

How to Prepare for a Successful Medical Device Design Transfer

Watch the Free On-Demand Webinar

 

All medical devices go through well defined stages in a product's lifecycle, and smooth transitions between these stages are critical. 

One of the most important (and often most difficult) transitions is the transfer from design to manufacturing. 

Whether a design transfer will be effective and successful is often determined long before the actual transfer. Your product development team needs to be thinking about this step long before it takes place and involve manufacturing in the design phase.

How well you manage your design transfer will ultimately determine how successful or unsuccessful your product will be in the marketplace. 

During the free 90 minute webinar, Michael Drues, Ph.D., President of Vascular Sciences, will present what it takes to prepare for a successful design transfer. Jon and Mike will also be going over a real case study of the design transfer process hinting on common pitfalls to avoid.

 

Specifically you will learn:

  • How to best meet FDA requirements
  • Discussing some of the more common problems that arise
  • Meeting compliance requirements to facilitate successful design transfer
  • Real case study of the design transfer process 

And these questions will be answered:

  • What is design transfer?
  • Why is design transfer important?
  • How early in the development process should we think about design transfer?
  • What does the regulation say?
  • What are the challenges of design transfer for the future?

*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


Presenters

 michael_drues

Michael Drues, Ph.D.
President
Vascular Sciences

 

 jon_speer

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.


 

 

FEATURED IN