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31 March - 2 April 2020 // Nuremberg, Germany

This is what MedtecLIVE and MedTech Summit 2019 have to offer.

Assessing Biocompatibility and Sterilization Validations in a Challenging Regulatory Climate

Assessing Biocompatibility and Sterilization Validations in a Challenging Regulatory Climate

In cooperation with

Sterigenics Nelson Labs NV

Contact

Katrien Salens

+32 16 40 04 84

send enquiry

Bombarded almost daily with updates concerning changing regulatory requirements like the new European MDR and updated ISO 10993, medical device manufacturers risk losing a clear perspective and understanding of the impact of these new regulations and ensuring that they are prepared to comply.

This one-day seminar will help manufacturers understand the range of impact that will come from the EU MDR and will provide hands-on guidance on how to start from gap analysis to a final readiness plan. While doing this, our experts will take you through the full range of services to meet the requirements of ISO 10993 including Chemical Characterization, Biocompatibility, and Toxicological Assessments of medical devices.

To complete the circle, seminar participants will also enjoy classes taught by Sterigenics’ EO Sterilization expert Dr Stefan Reisbacher.
With careful preparation, a successful transition to the new regulatory landscape is possible!

Speakers: Thor Rollins, David Moreels, Stefan Reisbacher (Sterigenics) & Dr. Bassil Akra (TUV SUD).

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