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Chiara Picotti

Eurofins Medical Device Testing

With a degree as Biomedical Engineer Chiara Picotti has strong experience in the biological evaluation of medical devices and toxicological evaluations of E&L studies on medical devices, pharmaceutical packaging and process components. She was professor of Regulatory Aspects in Toxicology at Milan University. Currently she is the Business Unit Manager of the Consulting group at Eurofins Medical Device Testing. She is an active member of ISO/TC 194 for biological evaluation of medical devices.

Learn more about Eurofins Medical Device Testing, visit their website!


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Session:

Chemical Characterisation: a prerequisite for the biological evaluation

Location Einstein C Room Start / end time 4:00 pm to 4:45 pm

Following the approval of the Final Draft of ISO 10993-18 (ISO/FDIS 10993-18:2019, Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process) in June 2019, the final publication is expected early 2020. The focus of chemical characterization will not only be to evaluate the raw materials but also to take into account the presence of any impurities or residues associated with the manufacturing and sterilization process that may impact medical devices biocompatibility. Chemical characterization becomes a key factor in the assessment of the biological evaluation since obtained data are fundamental to correctly set the biological risk assessment of medical devices and also to plan how to evaluate biological effects relevant to the device.

This workshop will provide an up-to-date overview on normative changes of the new ISO 10993-18 in relation with the biological evaluation of devices and planning for future testing.