WHY I SHOULD JOIN THE WEBINAR:
“Safety” is mentioned almost 250 times in the MDR 2017/745 and our glorious “essential requirements” of MDD are now “general safety and performance requirements” meaning that safety is essential for a medical device to be put on the market in Europe.
Safety is a tripartite concept: our aim is the protection of the safety of patients or users or other persons.
ISO 10993 is mainly covering the safety of the patient and not everything is required by MDR is included in this series therefore further evaluations are required to be in compliance with regulatory requirements.
A comparison between GSPR dealing with biocompatibility and the relevant parts of ISO 10993 series will be presented pointing out the strengths and the weakness. The long way to have the ISO 10993 series harmonised will be presented as well.
- MDR and safety
- How to be in compliance with MDR
- ISO 10993 series: strengths and the weakness
- Harmonised standards
- How think out of the “ISO 10993 box”
WHO SHOULD PARTICIPATE:
- Procurement Manager
- R&D Managers
- QA Managers
- Regulatory Managers
- Production Managers
- Validation Managers
EVENT KEY NOTE SPEAKER:
Paolo Pescio, ERT
European Registered Toxicologist with a M.S. in Applied Toxicology and Biomedical Engineering has over 15 years of experience in biological evaluation of medical devices with a successful background as Study Director and Test Facility Manager.
He is Senior Scientific Director in Eurofins Medical Device Testing Europe, member of ISO TC194 and CEN TC 206 and adjunct professor at the University of Milan and Fondazione Alma Mater of Bologna.
He is a former Healthcare Engineering HAS consultant for EU Commission
** Israel Time Zone