ServiceUpdated on 24 February 2025

IVDR Compliance Service for health institutions, laboratories and manufacturers

Andreas Oberleitner

Chief Regulatory Officer at Platomics GmbH

Vienna, Austria

About

We provide services around IVDR compliance for different stakeholders. Laboratories and health institutions can create their technical documentation on diagnostic tests on a highly automated way on our platform PlatoX(R). Manufacturers can register their products on our platform, to make them processible for labs. We support in art. 5(5) In-House compliance and planning essential steps such as setting up QMS according to ISO15189, Risk Management, and Validation, and provide general and individual Trainings.

Type

  • Consulting
  • Others

Organisation

Platomics GmbH

Professional Service Provider

Vienna, Austria

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