Our kick-off webinar will introduce you to Platomics, our IVDReady Program, our partners, and IVD Assistant, our platform for compliance.
The first thing your lab needs is a strategy for documenting workflows, whether you’ve got 50 or 250 in-house tests. This webinar will outline several possible approaches.
The next step is formulating the intended purpose for your in-house tests. From here this webinar will also cover documenting qualification as a medical device and risk classification under IVDR.
This webinar will outline Platomics’ regulatory knowledge base that supports labs in understanding what exactly the IVDR requires of them.
Here we’ll show how our Workflow Studio quickly allows your lab to create compliant workflows by integrating manufacturers’ components plus the required documentation from the manufacturer.
Lernen Sie unsere Herstellerpartner kennen und erfahren Sie mehr über die Best-Practice-Workflows, die wir gemeinsam mit diesen auf unserer Plattform entwickeln.
GSPRs sind anspruchsvoll, und genau darin liegt die Schönheit etablierter Standards: Sie sind state-of-the-art und können als solche zuverlässig die GSPRs erfüllen. Finden Sie heraus, was Ihr Labor tun muss und wie Sie es am besten angehen.
Um die Anforderungen zu erfüllen und die Sicherheit und Zuverlässigkeit für Patienten zu gewährleisten, müssen Labore über ein solides Risikomanagementverfahren verfügen. Dieses Webinar bietet Orientierung.
We’ll explain how to fulfill both IVDR and ISO 15189 requirements regarding verification and validation, and how there is no “one size fits all” on this issue.
We’ll take you through various aspects of product excellence required by IVDR, from instructions for use to labeling, SOPs and documenting the design and manufacturing of your in-house tests and components.
Perhaps the most daunting aspect of the IVDR for labs are the new requirements for clinical use surveillance. We’ll explain what active vigilance throughout the life cycle of your in-house tests means for your lab.
Our final webinar will offer an outlook on important aspects for remaining IVDR compliant, including what is coming in the final phase of implementation in 2028.
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.