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09:00 - 09:10 10 mins
Main agenda
Chair's opening remarks
  • Barbara Musi - Principal Research Scientist, Baxter Healthcare +TC 194 working group
09:10 - 09:40 30 mins
Main agenda
Ensure devices meet biocompatibility requirements for approval to Asian Market.
  • Xin Tang PhD - Senior Research Manager/ Technical Fellow, Medtronic
  • Design and implement biocompatibility test strategy for successful product registration in China
  • Case studies of chemical characterization and toxicological risk assessments in response to CFDA inquiries
  • Updates on biocompatibility standards and policies in China.
  • Delivered by teleconference 
09:40 - 10:10 30 mins
Main agenda
Assessing the impact the EU MDR will have on biocompatibility
  • Daniel Shoukier - CEO, Bellingswood Consulting
  • Understanding the differences between the EU MDR and ISO 10993
  • Assessing the impact the MDR will have on biocompatibility
  • Discussing how the changing Medical device classifications will impact biocompatibility testing
10:10 - 10:40 30 mins
Main agenda
Will the MDR changes to single use devices affect their biocompatibility testing
  • Dan Vukelich - President, Association of Medical Device Reprocessors (AMDR), USA
  • Biocompatibility and validation expectations of SUD reprocessors
  • Decontamination, cleaning, sterilization and performance validations and effects of residuals
  • Monitoring for OEM design changes
  • Assessing the impact the EU MDR will have on biocompatibility requirements for reprocessable devices

10:40 - 11:10 30 mins
Main agenda
Networking Break and Morning Coffee
11:10 - 11:40 30 mins
Main agenda
Notified body experience in avoiding biocompatibility pitfalls
  • Christina Reufsteck - Product Specialist, TÜV SÜD Product Service GmbH, Germany
  • Clarifying what common pitfalls are seen when industry tries to follow ISO 10993
  • Exploring common problems e.g. missing literature, no test plan, missing worst case analysis of products
  • Practical advice on how these challenges can be overcome
11:40 - 12:10 30 mins
Main agenda
Biocompatibility and quality systems: Notified Body audits
  • Henry Sibun - Director, Henry Sibun Associates Ltd, and External Notified Body Reviewer/Lead Auditor for , TÜV SÜD Product Service GmbH, UK
  • Manufacturer and Notified Body roles and responsibilities
  • Biocompatibility as part of a Quality Management System Process
  • Processes for design, change, documentation and post market surveillance
  • Common non-conformities at Notified Body audits
12:10 - 12:40 30 mins
Main agenda
How to use histopathology to assess biocompatibility
  • Laurence MAUNIER - CSO Biotech, HISTALIM
12:40 - 14:20 100 mins
Main agenda
Networking Lunch
14:00 - 14:30 30 mins
Main agenda
Toxicological assessment and acceptable thresholds for unidentified compounds
  • Simon Craige - Senior Medical Research Scientist, NAMSA
14:30 - 15:00 30 mins
Main agenda
Successfully complying with biocompatibility across the globe
  • Natalia Crespo - Regulatory affairs manager, Terumo - Europe
  • Discussing the differences in biocompatibility regulations when submitting devices across the globe.
  • Current experiences in South America, China and South Korea 
  • Is a globally harmonised biocompatibility scheme possible?
15:00 - 15:30 30 mins
Main agenda
Understanding latest changes to ISO 18562 Biocompatibility evaluation of breathing gas pathways in healthcare applications and implications for industry
  • Lars Magnus Bjursten - Professor Bioimplant Research, Convener for the Swedish TC194 – 10993 Series, Lund University, Sweden
  • Key changes implemented in the ISO  18562
  • Understanding why the changes to ISO 18562 is crucial
  •  How to successfully implement these changes
15:30 - 16:00 30 mins
Main agenda
Best practice for justification for biocompatibility test exemptions
  • Matt Smith - Senior Verification Engineer, Cochlear
  • Exploring examples of successful submissions with omitted tests
  • In vitro vs in vivo testing
  • Practical examples of the logic behind chosen tests
16:00 - 16:30 30 mins
Main agenda
CASE STUDY: How to analyse end points to ensure successful risk assessment
  • Wilbert Pennings - Safety, Compliance & Regulatory Affairs Manager, Philips
  • Clarifying the importance of successful risk assessment
  • Practical examples of writing risk assessment
  • Understanding how to interpret end points to ensure successful risk assessments
16:30 - 16:30 0 mins
Main agenda
End of Conference