How to Globally Register a Medical Device?
Instructor:
Frank Stein
Product ID: 706890
Training Level: Intermediate
- Duration: 90 Min
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
Frank Stein
Senior Expert Medical Devices, Frank Stein healthcare projects
Prof. Dr. Dr. h.c. Frank Stein, medical engineer, medical engineering experience for 27 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, Brazil.
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