IVDReady by May 2024 with Platomics
Our kick-off webinar introduces IVDReady, a free one-year program that guides labs to full IVDR compliance
Our kick-off webinar introduces IVDReady, a free one-year program that guides labs to
full compliance for the next round of IVDR requirements pending on May 26, 2024.
This unique program offers a structured path to IVDR fulfillment via monthly webinars
and other activities that support your lab step by step through the requirements
for in-house tests.
Speakers include Platomics in-house regulatory expert Andreas Oberleitner and our guest Dr. Sonja Neuhofen, an expert on IVDR with a focus on
in-house diagnostic tests and in vitro diagnostic medical devices.
This webinar includes:
- an introduction to Platomics and our IVDReady program
- an overview of what IVDR means for labs
- an introduction to our program partners
- a demonstration of PlatoX® IVD Assistant*, our platform for compliance processes
*cost-free for health institutions for creating IVDR technical documentation for in-house tests
Watch the recorded webinar here:
Speaker
Dr. Sonja Neuhofen
Dr. Sonja Neuhofen has been a freelance trainer in medical device law since 2016. Her specialization is on the IVDR with a particular focus on in-house devices, technical documentation and performance evaluation. Previously she gained 15 years of experience in the area of Regulatory Affairs and Quality Management working with various in vitro device manufacturers.