Nelson Labs Europe hosted a full-day Open House, February 28 in Leuven. The PDFs of the presentations from this seminar are now available. Contact [email protected] for more information.
Developing biocompatibility for medical devices: incorporating E&L, ISO, FDA, and MDR requirements
Speaker: Audrey Turley, B.S., RM(NRCM), CBA(ASQ), Senior Biocompatibility Expert – Nelson Labs
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: The basics
Dr. Annelies Vertommen, Senior Study Director – Nelson Labs Europe (TC 194 member)
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.
View the presentation here.
Medical Device Line for Chemical Characterization: Moving beyond the current state-of-the-art (techniques & instruments); including the Nelson Labs Unique Compounds Screener Database
Speaker: Dr. Piet Christiaens, Scientific Director – Nelson Labs Europe
(TC 194 member, Scientific Director)
This presentation will consist of three sections. In the first section, we discuss the Unique Nelson Labs Compounds Screener Database as a key differentiator in obtaining high quality results for chemical characterization studies. The second section will explain the typical errors you can make during the process of organic chromatographic screening and how to substantially reduce or eliminate the occurrence of such errors by using of a well-populated screener database. In the final section of the presentation, we highlight the Nelson Labs’ Medical Device Line, the objective for designing the line, how it looks today, and how it will optimize our future chemical characterization project offerings.
Download the presentation slides here.
Submission Requirements for Chemical Characterization Studies of Medical Devices
Notified Body Perspective
Speaker: Dr. Julian Kirch, TÜV SÜD Product Service GmbH
Because ISO 10993-18 does not provide an unambiguous framework regarding the design, conduct, and required capability of chemical characterization studies for medical devices, it is crucial to address the respective individual requirements with regard to the above points during regulatory submissions to your notified body. This presentation aims to provide helpful information on common pitfalls in such submissions and practicable solutions in the identification and justification of the appropriate methods for chemical characterization (E/L studies).
Download the presentation slides here.
Toxicological risk assessment on E&L for medical devices
Speaker: Dr Koen Van Deun
Risk assessments of medical devices are based on exposure versus hazard assessment. Major toxicological endpoints, typical limits according to ISO 10993-17, and hazard evaluation methods are illustrated. Endpoints include genotoxicity and carcinogenicity, sensitization potential, local tolerance, general systemic toxicity, and reproductive and developmental toxicity. Finally, some new requirements of the Medical Device Regulation are discussed, which are related to the toxicological endpoints.
Download the presentation slides here.
Current Successes and Vision for the Future
Keynote Speaker: Ron Brown (ex-FDA)
Download the presentation slides here.
