How to Globally Register a Medical Device?

Attend this webinar if you are faced with the task of having to register a product worldwide and need to think about the most sensible and efficient way to do so. The correct order of the countries and the provision of the documents and what the differences are between the various technical dossiers of the countries are often decisive here.

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Why Should You Attend:

Medical device regulations in different regions of the world may have similarities and differences. In this webinar, you will first learn to get an overview of the different regions of the world and how you could build a regulatory strategy and what the key factors are here for deciding which route of product approvals makes sense.

Learning Objectives:
  • Introduction, who needs a global medical device registration strategy?
  • What are the key points in a global medical device registration strategy?
  • Smart and fast ways to implement a global medical device registration strategy in your quality management system and your technical files.
Areas Covered in the Webinar:
  • How to define a global medical device registration strategy?
  • How to build up a technical dossier for the global medical device registration strategy?
  • How to implement the strategy in the relevant quality management processes?
  • How to keep the stratey up to date?
Who Will Benefit:

CEO’s, product manager, quality/ regulatory / medical affairs manager, quality representatives of

  • medical device manufacturers
  • importer
  • distributors
  • dealers
Instructor Profile:
Frank Stein Frank Stein

Senior Expert Medical Devices, Frank Stein healthcare projects

Dr. h.c. Frank Stein, medical engineer, medical engineering experience since 25 years, clinical and research experience in cardiac surgery and cardiology, industrial experience in ophthalmology, neurology, traumatology and dental implants, active implants, active devices, international project and regulatory consulting experience in Europe, North-America, Asia, Australia, Arabic Countries, Latin-America.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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