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Alexander Fink

Geschäftsführer

Metecon GmbH

Mannheim, Germany

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As founder of Metecon GmbH, I can offer 25+ years of experience in the regulatory field. Digitalization of regulatory workflows is my favourite topic.

My organisation

Metecon GmbH

Metecon GmbH

Service providers and consultants

Mannheim, Germany

Metecon GmbH is one of the pioneers in Germany when it comes to standard- and guideline-compliant consulting and support for medical device manufacturers and manufacturers of IVDs: Since 1999, we have been a strategic partner for our customers in the creation and maintenance of product files for medical devices and IVDs, in the verification and validation of these products, for all aspects in the areas of clinical affairs and regulatory affairs, and in the optimization of quality management processes. Our customers are startups, SMEs and corporations. We put together project teams according to our customers' needs; due to the size of our company, we can draw from a wide range of resources: no matter what expertise you need, we are ideally positioned. For us, there is no such thing as "too small" or "too big" - we see manufacturers of medical devices and IVDs that we can help to enter the market and maintain existing certificates with our know-how and experience.
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About me

  • background: biomedical engineering

  • Founding Metecon GmbH in 1999

  • forming Metecon into a full service provider for regulatory affairs of medical devices and IVD with ca. 60 employees

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Speaker sessions (1)

Wednesday, 15 October 2025

11:00 - 12:15

A1: Softwaretools for supporting regulatory affairs

Location:Room 1: Maria Theresia

Moderator: Martin Schmid