ISO 13485 certified

Quality is one of the most important characteristics with medical products, because every defect can affect the efficacy of the product and the safety of the patient and user.

When registering a medical product or pharmaceutical product, creation of complete documentation is mandatory for you as OEM.
pheneo is therefore not only DIN EN 13485 certified and DIMDI (German Institute for Medical Documentation and Information) listed, but as part of our customer relations you also receive product-related, complete documentation and support for your documents to be submitted, both of which are internationally recognised.

And this not only applies to our own product range, but of course also for every exclusively developed product.
You thus avoid costs in monitoring the supply chain and shorten the internal process for creating the necessary documents.

Download the certificate as PDF