Platomics announces new collaborations Read the Press Releases
Understanding IVDR IH-IVD Scenarios: A Practical Guide for Laboratories
With the implementation of the In Vitro Diagnostic Regulation (IVDR), laboratories across Europe are…
Platomics announces new collaborations Read the Press Releases
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Read MoreUnderstanding IVDR IH-IVD Scenarios: A Practical Guide for Laboratories
IVDR 2.0 and Article 5(5): What Could Change for In-House IVDs?
Most of the regulatory debate over the past years has focused on manufacturers under…
IH-IVD vs Examination Procedure: Where ISO 15189 Stops
In the fast-evolving world of diagnostic testing, many laboratories rely on in-house developed tests…
One Year into the core of IVDR Article 5(5) – What Have We Learned?
26 May 2024 marked a major regulatory threshold for laboratories across Europe using in-house…
The Importance of Continuous Learning in the Lab
How Ongoing Education Keeps Your Lab Compliant, Competitive, and Ready for What’s Next The…
Verification vs. Validation: When do I need which in the lab?
Understanding the difference will save your lab time and effort—and streamline compliance In a…
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 recently released ISO 5649:2024…
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 innovation? The past few…
To document or not to document? General laboratory equipment under IVDR
Pipettes, centrifuges and the spin cycle of compliance General laboratory instruments, also known as…
More bread and butter, please: Risk management under IVDR
How labs might deliver on a rather tall order The IVDR has reshaped lab…
An overview of the latest IVDR timeline changes
The EC has now published an extended IVDR timeline that helps manufacturers but does…
Is an ounce of validation enough?
Validation under ISO 15189 vs. performance evaluation under IVDR Before IVDR, many EU labs…
Is ISO 15189 accreditation enough?
The short answer: No, typically not We are often asked if it is enough…
Ireland moves to support labs with IVDR
Ireland has taken a rather vigorous approach to IVDR and is findingways to get…
Looking back and looking forward
What a year! What an amazing year for Platomics! We have grown into an…
Who’s who in the IVDR?
What labs need to know about the roles of the EU, national competent authorities,…
An annotated rundown of IVDR requirements for labs
2024 brings a new set of challenges The IVDR was written primarily with IVD…
What’s a Workflow Studio for, anyway?
Our Workflow Studio has gone live and we’ve opened the gates! But wait a…
Innovation to patient, faster
Want to know why that’s our credo as we build an IVDR compliance platform…
We offer a clear path to IVDR conformity for your in-house tests.
Andreas Oberleitner, Platomics’ regulatory expert, on the benefits of the IVDReady Program Our platform…
Greetings to the unsung heroes of the IVDR!
Platomics is declaring May 26 IVDR Day – but not only to highlight the…