Platomics announces new collaborations Read the Press Releases
Digital Files Are Not Digitalization: Rethinking IVDR Technical Documentation
Rethinking IVDR Technical Documentation – Part 1 of 4 Introduction IVDR…
Platomics announces new collaborations Read the Press Releases
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The CE Mark Mystery: What It Really Means in a Diagnostic Laboratory
Have you ever looked around a diagnostic laboratory and wondered…
Understanding IVDR IH-IVD Scenarios: A Practical Guide for Laboratories
With the implementation of the In Vitro Diagnostic Regulation (IVDR),…
IVDR 2.0 and Article 5(5): What Could Change for In-House IVDs?
Most of the regulatory debate over the past years has…
IH-IVD vs Examination Procedure: Where ISO 15189 Stops
In the fast-evolving world of diagnostic testing, many laboratories rely…
One Year into the core of IVDR Article 5(5) – What Have We Learned?
26 May 2024 marked a major regulatory threshold for laboratories…
The Importance of Continuous Learning in the Lab
How Ongoing Education Keeps Your Lab Compliant, Competitive, and Ready…
Verification vs. Validation: When do I need which in the lab?
Understanding the difference will save your lab time and effort—and…
ISO 5649: A beautiful standard that points the way toward IVDR compliance
Here’s what the standard can—and cannot—do for EU labs The…
IVDR 2.0 is now inevitable. But what will a reform mean for manufacturers and labs?
And how might the EU try to balance regulation and…