Biological Safety Spotlight: Surface-contacting Medical Devices. Current requirements and pitfalls explained using case studies
In the third webinar of this series, “Biological Safety Spotlight: Surface-contacting Medical Devices. Current requirements and pitfalls explained using case studies” we will evaluate requirements and standards applying for surface contacting medical devices, analyze specific cases and best practices in approaching biological evaluation plan and testing strategy for surface-contacting medical devices.
Access webinar on-demand (English version)
Access webinar on-demand (German version)
About the webinar:
Eurofins Medical Device Consulting & Eurofins Medical Device Testing group of laboratories present new webinar series on biocompatibility of medical devices.
Biological safety of medical devices is a key concept in developing well-performing, reliable and robust medical products. Such complex topic can hardly be applied to all medical devices at once. In the “Biological Safety Spotlight” series we will concentrate on analyzing certain medical devices classes, focusing on specific challenges and problems that medical device manufacturers encounter.
In the third webinar of this series, “Biological Safety Spotlight: Surface-contacting Medical Devices. Current requirements and pitfalls explained using case studies” we will evaluate requirements and standards applying for surface contacting medical devices, analyze specific cases and best practices in approaching biological evaluation plan and testing strategy for surface-contacting medical devices.
Following questions are going to be covered during the live event:
- Biocompatibility assessment to meet requirements of ISO 10993-1 and further relevant vertical standards
• Establishment of Biological Evaluation Plan testing strategy
• Particular considerations regarding device composition, clinical use, application duration, and exposure route
• Describing pitfalls with exemplary case studies, e.g. tooth aligner, wound dressings
At the end of the webinar there is going to be a live Q&A Session.
This webinar is presented by Marcel Dörkes, Deputy Head of Consulting, Eurofins Medical Device Consulting.
Two sessions are offered for this event:
Session in GERMAN, 24.11.22., 11:00-12:00 CET
Session in ENGLISH, 24.11.22., 16:00-17:00 CET
Speaker:
Marcel Dörkes, Deputy Head of BioPharma Services Consulting Munich GmbH
Marcel Dörkes has an academic degree (MSc) in molecular biology and an advanced toxicological expertise by further training e.g. participation in the graduate program for European Registered Toxicologist. Marcel has been working in the field of evaluating the biological safety of medical devices and is employed as Consulting Specialist at Eurofins BioPharma Services Consulting Munich GmbH in Planegg, Germany, since February 2018. Marcel Dörkes' expertise includes the biological safety assessment of medical devices and related toxicological issues including strategy planning, chemical characterization procedures and overall biological risk assessments.
