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STREAMLINED REGULATORY PROCESSES
Platomics regulatory services and the PlatoX® platform simplify and accelerate compliance
for your lab customers
Our lab solutions also benefit manufacturers
EU labs and IVD manufacturers are both subject to strict new IVDR requirements. Labs are now considered the manufacturer of their in-house tests—which is new territory that has added complexity, uncertainty and an unfamiliar workload.
Registering your products on PlatoX® ensures that labs have instant access to regulatory product data for efficiently generating technical documentation, as well as a structured path for documenting their workflows with your products.
We also offer lab services that enable workflow validation and faster implementation of ISO 15189 for lab quality management, a standard now required under IVDR.
Benefits
Faster
PlatoX® offers integrated regulatory knowledge, clearly structured digital files and a basic support package that empowers labs to understand and quickly complete the technical documentation for their in-house tests. This means your products are in service faster and are appropriately documented in lab workflows.
Easier
Uploading your products once onto the PlatoX® product database enables all EU labs on our platform automated access to essential product data for their regulatory work—making lab compliance easier for both you and your customers.
Less risk
Once labs have completed their technical documentation for an in-house workflow on our platform, they have confirmed and documented a formal shift of responsibility for the workflow to the lab in accordance with IVDR Article 5(5).
Partner with Platomics to support labs
Collaborate with Platomics to enable your lab customers to accelerate IVDR compliance, save resources and document a high level of quality. This is particularly an advantage for labs with many in-house tests, for example those with a focus on rare diseases or oncology.
We provide the tools, information and know-how to help your lab customers get compliance done faster and easier.
Get in touch
Platomics GmbH
Jakov-Lind-Strasse 15/3
1020 Vienna
AUSTRIA
