Daniel Wieser

The EC has now published an extended IVDR timeline that helps manufacturers but does little to ease the burden on labs.  In the hopes of preventing a supply disruption of in vitro diagnostic medical devices for EU patients, the European…

Validation under ISO 15189 vs. performance evaluation under IVDR Before IVDR, many EU labs routinely validated their lab-developed tests in the course of following ISO 15189. And so the assumption may be that following the method validation approach of this…

The short answer: No, typically not We are often asked if it is enough for a lab to be ISO 15189 accredited to fulfill IVDR quality requirements.  The short answer here is: No, it is not enough now that lab-developed…

Ireland has taken a rather vigorous approach to IVDR and is findingways to get labs active, too. The most recent sign of this: The Irish Health Products Regulatory Authority, or HPRA, published a draft guide for Irish health institutions that…

What a year! What an amazing year for Platomics! We have grown into an incredible team of ca. 120 regulatory, medical, IT, business and people experts from 29 different countries, and still hiring. We have spread our wings to encompass…

What labs need to know about the roles of the EU, national competent authorities, accreditation bodies and MDCG Big news last week was agreement in the EU on the cornerstones of an AI Act. While not the first such proposed…

2024 brings a new set of challenges The IVDR was written primarily with IVD manufacturers in mind, but notably Article 5.5 also makes demands on in-house diagnostic tests developed by labs. And 2024 will bring another round of IVDR rollout…

Our Workflow Studio has gone live and we’ve opened the gates! But wait a minute, the IVDR says that labs must document their in-house tests. So one question we often hear is: Why document entire workflows?  Let’s start at the…

Want to know why that’s our credo as we build an IVDR compliance platform for labs and manufacturers? Dig into this top-read genomeweb story that sets the current regulatory scene for EU labs and global manufacturers under IVDR. (Spoiler alert:…

Andreas Oberleitner, Platomics’ regulatory expert, on the benefits of the IVDReady Program Our platform for automating the generation of documentation and other regulatory processes under IVDR offers diagnostic labs increased efficiency, improved collaboration, enhanced traceability, and streamlined regulatory compliance. It…