There is no doubt about the mantra that the IVDR was enacted to ensure that diagnostic tests are
safe and effective for patients, but the naked reality is that most labs still lack the resources and specialized
knowledge that are vital to seeing IVDR through.
As a manufacturer of IVD medical device software, Platomics early on faced the intricacies of IVDR and was able
to invest heavily in RA a few years ago.
One of the fruits of our efforts is now going live: PlatoX® IVD Assistant, a compliance platform for labs and manufacturers.
But we also recognized that more was needed to support labs in getting started. So we have developed IVDReady, a free one-year program designed to share with labs the expertise we have accumulated.
Knowing that the road to compliance can be long and hard – a real “slog” – we have also created this IVDR Slog Blog to lighten your load and hopefully your spirits as well! Here you will find news and tips, etc, from our regulatory experts.
Join us and get ready to celebrate next year’s May 26 IVDR Day with your very own set of safe, effective and compliant in-house diagnostic tests.