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 supports the transition to a more efficient and transparent regulatory environment for in vitro diagnostics, ultimately contributing to patient safety and the availability of high-quality diagnostic testing.

Meeting IVDR requirements for in-house diagnostic testing is a legal requirement and a major challenge for many laboratories. There is a lack of time, human and financial resources, and knowledge around this topic.
Our tailored IVDReady program and IVD Assistant platform provide support on several levels. We offer insight into the regulatory requirements as well as solution strategies, compliant templates for documentation, and efficient content creation via wizards.

See our IVDReady kickoff webinar to learn more about the benefits of our 12-month program that guides labs to IVDR compliance for their in-house tests:

IVDReady by May 2024 with Platomics
Available soon online in German and English

Speakers included Andreas Oberleitner and our guest Dr. Sonja Neuhofen, an IVDR expert with 23 years of experience advising labs and manufacturers on medical device law.