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Assessing Biocompatibility and Sterilization Validations in a Challenging Regulatory Climate – Presentations

Nelson Labs hosted a full-day Seminar, May 22 in Nuremberg. The PDFs of the presentations from this seminar are now available. Contact Infoeurope@nelsonlabs.com for more information.


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.

Download the presentation slides here.


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.

Download the presentation slides here.


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 expecting 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.

Download the presentation slides here.


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’ll elaborate on the Unique Nelson Labs Compounds Screener Database as a key differentiator in obtaining high quality results for chemical characterization studies.

Download the presentation slides here.


Toxicology Assessments:  How to identify and lower your risks

Speaker: Thor Rollins

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

Download the presentation slides here.


European Union MDR Impact on Device Manufacturers – A Notified Body Perspective

Speaker: Dr. Bassil Akra, Tüv Süd

Download the presentation slides here.