Legal role as manufacturer

Diapharm is committed to its responsibility. We can act as manufacturer on our clients’ behalf as defined in Directives 93/42/EEC (medical devices) or 98/79/EC (in vitro diagnostics).

Marketed under the client’s brand name

All products are marketed entirely with the brand name and corporate identity of the client or its appointed marketing partner. The actual manufacturing of the product can be outsourced to one or more suitable contract manufacturers. The patient information leaflet and the packaging refer to the name and address of Diapharm.

We are legal manufacturer of 31.000.000 packs of medical devices currently on the market in Europe.

Quality management by Diapharm

ISO 13485: quality management for medical devices

In this scenario, Diapharm and HÄLSA Pharma GmbH are responsible for acting as a manufacturer (including the conformity assessment procedure and product maintenance) and controlling the production (including batch release) as well as the fully certified quality management system. Our clients can rely on our services, allowing them to fulfil all the standards set forth in ISO 13485 for medical devices without having to establish their own quality management systems. As a result, pharmaceutical companies do not have to expand and modify their existing GMP-compliant QM systems just to include medical devices, to name just one benefit. This give marketing companies a convenient and safe way to expand their product portfolios to include medical devices and IVDs.