ISO 10993-18:2020 - Important Changes & Possible Strategies
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About the webinar
The new ISO 10993-18:2020 standard was published in January, 2020.
The new release of ISO 10993-18 defines the framework for identification and quantification of constituents of a medical device, which outcome is useful for the further testing strategy regarding the biological safety evaluation of your medical device. The question medical device manufacturer may have after the revision of the first edition, issued in 2005 is: What impact would the new standard have for my medical device?
The live webinar “ISO 10993-18:2020 - Important Changes & Possible Strategies” will inform you about the changes in the standard and on the most significant consequences of the revision. Some key questions to be discussed on the webinar are:
- What are the most important changes in the standard?
- What are the potential improvement areas in chemical characterization according to the new release?
- What is the impact of the revisions regarding the testing strategy?
- How do you identify the possible risks for your product and what strategies should you implement to react to the updates?
At the end of the webinar session there is going to be a Q&A Session with the expert, where you would get a chance to clarify some specific cases.
Speaker
Jan Peeters, Senior Consulting Specialist, Eurofins Professional Scientific Services Germany GmbH
Jan Peeters has been working in the field of testing and evaluating the safety of medical devices since 1995 and is employed as Senior Consulting Specialist at Eurofins Professional Scientific Services Germany GmbH in Planegg, Germany, since October 2017.
Jan Peeters' expertise includes the chemical characterization of medical devices and related toxicological issues, biocompatibility, packaging validation and stability testing, including transport simulations, validation of reprocessing methods and testing of ophthalmic products. He actively participates in many national and international standardization groups in the fields of biocompatibility, packaging and intraocular medical devices.
“ISO 10993-18:2020 - Important Changes & Possible Strategies”
The webinar is presented in ENGLISH.
