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Event info
Date:02 Oct
Venue:Medicon Village, Lund

Medicon Valley Medtech Network meeting


Join Medicon Valley Medtech Network and our next meeting!
Understanding Biocompatibility of Medical Devices
– biological evaluation and biocompatibility testing according to ISO 10993

Medical device manufacturers must conduct biological safety (biocompatibility) evaluations for their medical devices to meet regulatory obligations and receive approval to market medical devices. The complexity of this process is increasing due to new regulatory requirements. Do you have an updated strategy for the biological evaluation of your medical device products?

Welcome to join us at the next Medicon Valley MedTech Network meeting to learn more about ISO 10993* and the recent changes in the standard, and understand how to make a biological evaluation of your medical device products:

Date: 2nd of October, 2018
Time: 17.00- 20.00
Host: SenzaGen AB
Venue: Auditorium, Medicon Village, Lund

* ISO 10993; Biological Evaluation of Medical Devices – is the most widely used standard for assessing the biocompatibility of medical devices and materials, and provides a framework for determining the appropriate biocompatibility steps for planning a biological evaluation. Specific testing is dependent on the type of medical device or material and its intended use, and on the nature and duration of contact between the medical device and the body.

The Network
Joining the network is free of charge and is limited to Medicon Valley Alliance members. However, non-member organizations and companies are welcome to attend one network event to evaluate if being part of the network is relevant. If so, becoming a member of Medicon Valley Alliance will automatically able you to join the medtech network.

Sign up

Moderator: Rose-Marie Jenvert, Project Manager, SenzaGen AB

17.00-17.30 Registration, networking and a bite to eat
– meet the fellow participants
17.30-17.35 Welcome
Petter Hartman, CEO, Medicon Valley Alliance
Kerstin Jakobsson, CEO, Medicon Village Innovation
17.35-17.40 Sponsor of the event
Peter Borg Gaarde, Partner & European Patent Attorney, HØIBERG P/S
17.40-18.15 Introduction to Biocompatibility and ISO 10993
Monica Grekula, Business Area and Team Manager Toxicologist, Symbioteq
18.15-18.35 Chemical characterization according to ISO 10993-18
Carsten Senholt, Principal Toxicologist, SAXOCON
18.35-18.55 Industry perspective on hemocompatibility testing according to ISO 10993-4
Barbara Musi, Principal Research Scientist Toxicology & Biocompatibility, Baxter
18.55-19.25 Case study: Medical Device Biocompatibility Testing
Helge Gehrke, Head of in vitro Pharmacology and Toxicology, Eurofins Biopharma Product Testing Munich
19.25-19.30 Presentation of a business delegation from the Swiss Jura region
Gustav Henriksson, Head of Trade Section, trade Point Nordics, Embassy of Switzerland in Sweden
Jacques Gerber, Minister of economic affairs, Canton Jura
19.30 Wrap up
Rose-Marie Jenvert, Project Manager, SenzaGen AB
19.30-20.00 Networking and a light snack

Deadline for registration is 27th of September, 2018.

For more information please contact Senior Project Manager Helen Pettersson:



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