We are happy to announce that Nelson Labs will be exhibiting at the 2nd edition of VIRTUAL MedtecLIVE together with our sistercompany Sterignics. This year, the tradeshow will be held online and all presentations will be provided through a livestream page.
Nelson Labs will have consultants available to answer even the most difficult testing and compliance questions. Find more information on all our seminars at our seminars webpage.
To join the livestream for the virtual tradeshow, register via the website of MedtecLIVE now!
Also, two of our Expert Advisers will present some interesting topics at the event. All information on the presentations, as well as the speakers biographies, you may find below.
LIVE PRESENTATION: The Benefits of Family Grouping of medical devices prior to performing Reprocessing Validations
Presenter: Lise Vanderkelen PhD, Department Head Micro Services Nelson Labs Europe
Wednesday, 21 April 2021, from 14.00 to 14.20 hrs. CET
LIVE PRESENTATION: The New FDA Draft Guidance for Biocompatibility of Certain Devices in Contact with Intact Skin: The Naughty and Nice list
Presenter: Thor Rollins, Director Toxicology and E&L Consulting Nelson Labs
Wednesday, 21 April 2021, from 14.20 to 14.40 hrs. CET
In October of 2020 the FDA released a new draft biocompatibility guidance document. This new draft focuses on the biological evaluation of devices in contact with intact skin. This document signifies another step from the FDA toward their 3R animal initiative (reduce, refine, and replace animal use in testing when feasible).
In this webinar we will go into detail on this new FDA draft document.
- We will give flavor on why the FDA released this guidance and what it means for skin contacting medical devices.
- We will look at the list of materials that fall into the guidance (the nice list) and then the ones that are excluded (the naughty list).
- We will also cover what should be included in your submission of these materials to make sure you have success with your FDA submission.