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.
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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. |
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 | 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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