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.
Program
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: hp@mva.org
Sponsors
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In collaboration
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