There are minimum requirements for the safety of products and devices within the European Union. These requirements are stipulated in directives (here: the European Medical Device Directive). In this regard, the producer of a device has several responsibilities: The producer must identify which directives are relevant and whether all requirements are met. If need be, an inspection authority must be employed for this assessment.
We are your reliable interface to inspection authorities, authorities and associations of SHI accredited physicians and can assist you in achieving compliance with the requirements you, your medical device and your documentation must meet.
Benefit from our long-term international experience in the fields of testing, development and approval of medical devices. You will find a summary of our services on this page.
