Event info
Date:25 May
Time:4 pm CEST
Venue:Online
Contact person
Sofia Norås

Sofia Norås

Project Manager

sn@mva.org

+45 2337 0040

Medical devises’ principal mode of action by physical means: Case study on 3D reconstructed human tissues

This webinar will showcase the opportunities offered by 3D reconstructed human tissues to demonstrate the physical mode of action of medical devices in line with the requirements and ethical criteria of the EU Medical Devices Regulation (MDR) 2017/745.

Key takeaways:

  • How the principles of the 3Rs are applied in the MDR’s requirements.
  • How 3D reconstructed human tissues become a robust tool to define and demonstrate the principal mode of action of medical devices.
  • How to assess on a case by case approach the physical mode of action of medical devices according to their different therapeutic areas.

 

Read more and register

Speakers:

Laura Ceriotti, PhD
Regulatory Specialist, VitroScreen srl
As Regulatory Specialist at VitroScreen, Dr Laura Ceriotti monitors law frameworks, and regulatory and technical guidelines to provide updated in vitro preclinical testing strategies and regulatory compliant justifications.
 
Paolo Buratti, PhD
Study Director, VitroScreen srl
As GLP Study Director at VitroScreen, Dr Paolo Buratti is responsible for in vitro pre-clinical studies on reconstructed human tissues for pharmaceuticals, agrochemicals, medical devices and cosmetics industries.

 

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