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Assessing Biocompatibility and Sterilization Validations in a Challenging Regulatory Climate


May 22, 2019 - May 22, 2019


Free of Charge for MedtecLive attendees


MedTecLive - Exhibition Centre Nuremberg - Restaurant Behaims

Contact Information

Katrien Salens
+32 16 40 04 84

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).

Date & Time: May 22, 2019 10-4 pm

10:00 – 11:00 Introduction to EO Sterilization and Regulatory Updates
Speaker: Dr. Stefan Reisbacher

Ethylene Oxide (EO) Sterilization is one of the most important methods for industrial sterilization of medical devices. Learn about the basic principles of EO sterilization and the associated regulatory requirements.

11:00 – 11:30 EO Packaging Design: Product Definition
Speaker: Dr. Stefan Reisbacher

The packaging design is an important aspect of your product definition process for EO sterilization validations. Learn about the special requirements for packaging of medical devices intended for EO sterilization.

11:30 – 13:00 Biocompatibility 10993-1: Case Studies and MDR Impact
Speaker: Thor Rollins

The approach to biocompatibility testing has changed as regulatory agencies from all around the world are suggesting a risk-based approach to testing and justifications. This means that “check box” compliance is no longer acceptable. Come hear the biocompatibility strategies that are helping our clients get through the toughest regulations.

13:00 – 13:30 Break

13:30 – 14:30 Chemical Characterization: How this testing will help you meet the new MDR—using our unique Compounds Screener Database to improve testing outcomes
Speaker: Dr David Moreels

This presentation describes the basics of a chemical characterization study according to ISO 10993-18, reviewing the three major steps: extraction, detection, and identification. In addition, you will learn how ISO 10993-18 and ISO 10993-17 are related. We will elaborate on the Unique Nelson Labs Compounds Screener Database as a key differentiator in obtaining high quality results for chemical characterization studies.

14:30 – 15:00 Toxicology Assessments:  How to identify and lower your risks
Speaker: Thor Rollins

Using chemical characterization to support the biocompatibility of medical devices has become a common occurrence—not only through increased acceptance, but also through heightened requirements.  Chemical Characterization of a medical device (per ISO 10993-18) has become an essential component of overall biocompatibility testing. This talk will present the framework in which we understand and design these programs, illustrate how they are performed, and close with an overview of how results are used within a toxicological risk assessment per ISO 10993-17.

15:00 – 15:45 European Union MDRs Impact on Device Manufacturers – A Notified Body Perspective
Speaker:  Dr. Bassil Akra, TUV SUD

15:45 – 16:00 Q&A
We end our program with an interactive Q&A, allowing you to address questions to the day’s presenters or to share any observations and experiences related to Biocompatibility, Chemical Characterization, Toxicological Assessments, and Sterility.