Date: 16 May, 2023
Time: 17:00h - 19:00h CEST | 11am - 1pm EST
Location: Virtual
Language: English
Costs: € 395,- / $ 426,60
Introduction
The biological and safety evaluation of legacy devices must be updated when manufacturer recertify their medical devices according to the MDR. This training aims to offer concrete strategies how to improve your documentation and make it compliant with the current requirements.
Agenda
- Gap assessment of applicable ISO 10993 standards
- Risk management of biological and chemical hazards
- Material and chemical characterisation
- Biological and chemical test strategy
- PMS data for the biological safety evaluation
- BSEP and BSER update
- Q&A
Learning Objective
Learn more about the most effective strategies for updating the BSEP and BSER for your legacy devices.
Qserve Trainers: