Regulatory categories

Medical devices

The manufacture of medical devices is subject to strict approval guidelines and legal regulations. FIDELIO Healthcare is familiar with the requirements and is your reliable partner for commercial production. Thanks to our extensive industry knowledge and expertise, we know how to bring new products to market successfully. Needless to say, we can also manufacture established medical devices in large quantities for our customers.

In contrast to medicinal products, medical devices do not generally intervene directly in the human metabolism or immune system. Instead, they have primarily a physical or physicochemical effect. However, the distinction between medical devices and medicinal products is not always clear cut and we will gladly advise you in case of doubt.

Medical devices

Safety first

FIDELIO Healthcare manufactures medical devices in compliance with all specific requirements and with the same precision as medicinal products.


Development & production from a single source

FIDELIO Healthcare offers first-class service, from the development of your product including trials and regulatory approval, to manufacturing, quality control and worldwide logistics.
Skilled specialists work on the optimal composition of diverse healthcare products. They carry out complex evaluations and extensive checks on the processes quickly and efficiently.
Contract manufacturing
Efficient production lines, a worldwide network of first-class raw material suppliers and specialized logistics service providers make FIDELIO Healthcare a specialist for the production of your pharmaceuticals.
Target markets
In addition to development and production, FIDELIO also takes care of the worldwide transport and the necessary country-specific requirements.
FIDELIO Healthcare Limburg GmbH

Mundipharmastraße 2
65549 Limburg an der Lahn
+49 6431 908830
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© FIDELIO Healthcare Limburg GmbH