Webinar: 5 Steps to Medical Device Commercialization in the U.S.

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Speed your medical devices to market by attending this complimentary webinar which takes you step by step through the process of submitting your medical devices for approval by the FDA. This webinar will provide an overview of the complex process and provide an understanding of the critical steps.

What participants will learn:

  • Classifying your device
  • Identifying the correct premarket submission
  • Preparing the premarket submission
  • Submitting to the FDA
  • Establishing a registration and device listing

 

Speakers

Michael Lynch, Managing Consultant, Intertek

Since 1981 Mike Lynch has worked almost exclusively in the Medical Device industry. Mike’s career started as a design and manufacturing engineer responsible for high volume disposable products. He progressed to leadership positions in R&D, product development, manufacturing, and marketing with a number of medical device companies spanning a diverse spectrum of products including orthopaedic and ophthalmic implants, electromechanical capital equipment, and single patient use diagnostic tests. Throughout Mike’s career he has led the implementation of product development, design control, and quality management systems.

 

Heather Thompson, Moderator, Medical Design & Outsourcing

Heather Thompson is senior editor for Medical Design & Outsourcing magazine. She has spent over a decade covering medical and diagnostic technologies for business publications, and is the former editor-in-chief of MD&DI.

 

 

 

Watch anytime on demand

 

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DeviceTalks West: Expertise you need to know

textadimage Medical device suppliers are light years away from the days when they merely filled orders to spec for medtech OEMs – as a visit to the upcoming DeviceTalks West will quickly confirm.

From incorporating steerability into catheters to getting validation and testing done right, the companies serving the medical device industry have become specialized experts in their own right.

Read on to discover five example of medical device expertise to be had at DeviceTalks West, which runs Dec. 11–12 in Orange County, Calif.

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