Medical Device Testing & Assessment
Webinar live
21 GIU 2022

New frontiers of biomedical devices testing | PART 4.1

Mastering the challenges of Biocompatibility

Online 2.30 pm - 4.00 pm CET

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. TÜV SÜD Group, by means of pH Labs, active in Biocompatibility & Chemical Testing (BCT), is in the optimal position to give a helpful contribution in the process leading to regulatory conformity.

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

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PROGRAM

  • 14.30 Introduction
    Riccardo Merello | Attilio Durantini
  • 14.35 Biocompatibility updates
    Christina Reufsteck TÜV SÜD - Product Service (Senior Product Specialist Biocompatibilty)
    Christoph Lindner TÜV SÜD - Product Service (Team Leader Medical Devices Testing)
    Relevant topics
    - New/updated biocompatibility standards
    - In vitro irritation tests
    - Chemical Characterization, E&L testing
    - Biological safety over the life-cycle
    - Conclusions

The main on-going evolutions of the applicable Standards will be presented and analyzed 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 & Marco Pucci pH Labs TÜV SÜD Group (Team Leaders of the Chemical Lab)
    Conversation on the following topics:
    - 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 critical situations regarding Chemical testing results
    - Conclusions

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

  • 15.45 Q&A
  • 15.55 Final session 
    Attilio Durantini

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