Free Webinar: In vitro testing approach for regulatory compliance

Taking into account medical device’s intended purpose, this presentation will present key strategic outcomes of in vitro testing to consider when developing your Medical Device testing strategy for safety and efficacy evaluation.

For example, ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation has been published 2 years ago. This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation by using an in vitro reconstructed human epidermis (RhE) model.

The introduction of the new ISO 10993-23 standard is leading the path towards the transition to alternative toxicology to assess the biocompatibility of devices. In vitro science, is evolving at a fast speed opening the possibility to introduce new testing approaches based on human reconstructed tissues. Consequently, a change in mind-set for which industry needs to prepare – fabricants need to be receptive and responsive to the new methods.

This event offers a unique opportunity to achieve a better understanding of the evolution of the ISO 10993 standard and the application of validated in vitro test methods. This webinar will provide sound knowledge on the implementation of an in vitro testing strategy, not only in the scope of the recent ISO 10993-23, but also on how alternative methods can be considered an effective and robust approach for efficacy and mechanism of action evaluation.

Thanks to the expertise achieved in developing in vitro testing methods, our experts will illustrate through specific examples, the range of success of in vitro testing methods as an alternative to in vivo testing.

• Regulatory requirements for mechanism of action, efficacy and safety
• Regulatory overview using in vitro methods:
  - Opportunities for addressing mechanism of action and efficacy through in vitro     
     methods
  - ISO 10993-23: in vitro assessment of irritation potential of medical devices
• Specific considerations and changes on sensitization test procedures
• Practical approach thorugh case studies:
  - In vitro safety assessment with direct and elution methods using mucosal models
  - Demonstration of the mechanism of action and efficacy through in vitro model
• Q&A session

Francesco Ranzini
Francesco has a degree in molecular biology and works in the Eurofins Italian Medical Device Business Unit as in vitro Laboratory Manager. Since 2011 he has been involved in research, development and validation of in vitro experimental models for safety and efficacy evaluation resulting in the publication of articles. He has a background of over 10 years in pharmaceutical/cosmetic area and 5 years of experience in  in vitro evaluation of medical devices.

Daniele Lioi
Daniele is a Senior Consultant and Team Manager of the Eurofins Italian Medical device consultancy team. He is dealing with Biological Risk assessments, Clinical Evaluation since 2017. He is also supporting the compilation of the technical documentation for medical device manufacturers. He has a biotechnology background with experience in regulatory affairs of medical devices. Daniele recently obtained the qualification as Auditor/Lead Auditor ISO 13485/ISO 9001. He is included in the national registry for person responsible for regulatory compliance and he has joined the HAS consultants team for the harmonization of International Standards.