Biocompatibility for Medical Devices is a conference dedicated to testing methods, evaluations, risk & regulations with competent authority, notified body & industry guidance.
Topics
- Hearing from ISO/TC 194 experts at the heart of ISO 10993
- James Moore, Senior Scientist, W.L. Gore, USA
- Christian Pellevoisin, Scientific Director, Episkin Academy, France
- Implantation working group
- Christopher Parker, Associate Department Head In-Vivo Biocompatibility, Toxikon and member, ISO/TC 194/WG 10
- Taking control of your biocompatibility strategy
- The latest alternatives to animal testing
- Common pitfalls and understand how they can be avoided
- Harmonisation of ISO 10993 in EU, US and China
- Direct Competent Authority and Notified Body feedback
- The guidance surrounding chemical characterisation and toxicological risk assement
- Gaining practical industry feedback to take back to your office
- The work Abbott is doing on Thrombogenicity Testing and the High Failure Rate
- How to manage TTC: What should manufacturers do with the information?
- Cytotoxicity failures? how to deal with them with Philippe Hasgall, Principal Scientist, Zimmer Biomet, Switzerland
Who should Attend
Attendees from medical device companies including:
- QA / Quality Assurance
- Biocompatibility Manager
- R&D / R&D Engineer
- RA / Regulatory Affairs within biocompatibility only
- Quality Engineer
- Toxicologist
- Product Safety
- Materials Specialist / Material Characterization / Material Expert
