Platomics announces new collaborations Read the Press Releases
IVDR 2.0 and Article 5(5): What Could Change for In-House IVDs?
Most of the regulatory debate over the past years has…
Platomics announces new collaborations Read the Press Releases
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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…
To document or not to document? General laboratory equipment under IVDR
Pipettes, centrifuges and the spin cycle of compliance General laboratory…