Platomics announces new collaborations Read the Press Releases
Platomics announces new collaborations Read the Press Releases
Rethinking IVDR Technical Documentation – Part 4 of 4 Table of Contents Introduction Not…
Rethinking IVDR Technical Documentation – Part 3 of 4 Introduction IVDR technical documentation is more…
Rethinking IVDR Technical Documentation – Part 2 of 4 Introduction IVDR technical documentation is more…
Rethinking IVDR Technical Documentation – Part 1 of 4 Introduction IVDR technical documentation is more…
Have you ever looked around a diagnostic laboratory and wondered what all those CE…
With the implementation of the In Vitro Diagnostic Regulation (IVDR), laboratories across Europe are…
Most of the regulatory debate over the past years has focused on manufacturers under…
In the fast-evolving world of diagnostic testing, many laboratories rely on in-house developed tests…
26 May 2024 marked a major regulatory threshold for laboratories across Europe using in-house…
How Ongoing Education Keeps Your Lab Compliant, Competitive, and Ready for What’s Next The…
Understanding the difference will save your lab time and effort—and streamline compliance In a…
Here’s what the standard can—and cannot—do for EU labs The recently released ISO 5649:2024…
And how might the EU try to balance regulation and innovation? The past few…
Pipettes, centrifuges and the spin cycle of compliance General laboratory instruments, also known as…
How labs might deliver on a rather tall order The IVDR has reshaped lab…
The EC has now published an extended IVDR timeline that helps manufacturers but does…
Validation under ISO 15189 vs. performance evaluation under IVDR Before IVDR, many EU labs…
The short answer: No, typically not We are often asked if it is enough…
Ireland has taken a rather vigorous approach to IVDR and is findingways to get…
What a year! What an amazing year for Platomics! We have grown into an…
What labs need to know about the roles of the EU, national competent authorities,…
2024 brings a new set of challenges The IVDR was written primarily with IVD…
Our Workflow Studio has gone live and we’ve opened the gates! But wait a…
Want to know why that’s our credo as we build an IVDR compliance platform…
Andreas Oberleitner, Platomics’ regulatory expert, on the benefits of the IVDReady Program Our platform…
Platomics is declaring May 26 IVDR Day – but not only to highlight the…
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