We are the holistic service provider for regulatory market access. We advise and support you in verification and validation as well as in documentation, market access and market monitoring of your medical devices and IVDs.
Sense and purpose of our work
We regularly experience that successful manufacturers of high quality medical devices and IVDs do not see their Notified Body and other surveillance authorities as partners with whom they jointly strive for optimal solutions, but perceive them as a threat. Therefore, we want to enable you, the manufacturers, to communicate with Notified Bodies and authorities as well as with users and patients on an equal footing.
We want to help ensure that the outstanding technical quality of your medical devices and in vitro diagnostics is also reflected in the processes and documentation. We see it as our success if you can concentrate on your technological competence and your processes and documentation allow uncomplicated and rapid market access. The fact that we also reduce your liability risks and increase the safety for your patients and users is another desired effect.