Biological Safety Spotlight: External Communicating Devices. Current requirements and pitfalls explained using case studies
Access our free live webinar “Biological Safety Spotlight: External Communicating Devices. Current requirements and pitfalls explained using case studies"
Eurofins Medical Device Consulting & Eurofins Medical Device Testing group of laboratories invites you to the second webinar of the Biological Safety Spotlight series.
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 concentrate on analyzing certain medical devices classes, focusing on specific challenges and problems that medical device manufacturers encounter.
In the second webinar of this series on the 21st of July, “Biological Safety Spotlight: External Communicating Devices. Current requirements and pitfalls explained using case studies” we will evaluate requirements and standards applying for External Communicating Medical Devices, analyze specific cases and best practices in approaching biological evaluation plan and testing strategy for external communicating devices.
Following questions are going to be covered during the live event:
- Biocompatiblity assessment to meet requirements of ISO 10993 series and MDR
- Establishment of Biological Evaluation Plan and Testing Strategy and usage of already available data in case of recertification
- Particular considerations for external communicating devices, e.g. Categorization in regard to cumulative application – prolonged or long-term, Chemical characterization – helpful tool or obstacle; How to deal with phthalates; Specialities with sample extraction; Etc.
- Describing pitfalls with exemplary case studies, e.g. surgical instruments, administration equipment, delivery systems, catheters and more
At the end of the webinar there is going to be a live Q&A Session.
This webinar is presented by Anja Friedrich, Head of Consulting, Eurofins Medical Device Consulting.
Access webinar on-demand (English version)
