New Frontiers of Biomedical Devices Testing

MASTERING THE CHALLENGES OF BIOCOMPATIBILITY 

The journey through the world of Medical Devices testing continues with this event, aiming to increase the awareness of what's new in the field. Join the webinar, organised by TÜV SÜD Group (pH Labs), to learn more about the Biocompatibility & Chemical Testing (BCT) process leading to regulatory conformity. 

Senior experts from the Notified Body TÜV SÜD in Munich, as well as recognised expert partners, and pH Labs scientists, herewith, provide their experiences on the hot topics of the moment. 

Date: 21 June 2022, Tuesday

Time: 2.30pm CEST

Duration: 1.5h (including Q&A)

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PROGRAM LINE UP 

14.30 - Introduction 

Riccardo Merello TÜV SÜD - Managing Director of pH Laboratories - TÜV Italia Group 

Attilio Durantini TÜV SÜD - Advisor for Medical Devices Testing at TÜV pH Laboratories

14.35 - Biocompatibility updates

Christina Reufsteck TÜV SÜD - Product Service (Senior Product Specialist Biocompatibility) 

Christoph Lindner TÜV SÜD - Product Service (Team Leader Medical Devices Testing)

• Key topics covered
  • New/ updated bio compatibility standards 
  • In vitro irritation tests 
  • Chemical Characterisation, E&L testing 
  • Biological safety over the lifecycle 
  • Conclusion

The main on-going evolutions of the applicable standards will be presented and analysed from the Notified Body perspective. 

15.05 - Q&A 

15.15 - Toxicological Risk Assessment: The Way for an Efficient Biological Evaluation 

Hana Hofman-Hüther H3 Consulting Services - Medical Device Expert and Certified Toxicologist Member of ISO/TC 194 

Riccardo Paladini TÜV SÜD - pH Laboratories TÜV SÜD Group (Team Leader Chemical Lab) 

Marco Pucci TÜV SÜD - pH Laboratories TÜV SÜD Group (Team Leader Chemical Lab)

• Key topics covered
  • Basic structure of ISO 10993-17 as it is now and its expected evolutions 
  • Opportunities for a lean overall biological evaluation 
  • Toxicologist, Lab and Manufacturers with a common goal: safety and performance of medical devices 
  • How to prevent and overcome crticial situations regarding chemical testing results 
  • Conclusion

The experiences of Toxicologist and Lab experts will be illustrated and discussed. 

15.45 - Q&A

15.55 - Final session 

Attilio Durantini