We bring your medical device efficiently to market and guarantee compliance with regulations throughout the entire product life cycle.
More than 25 years of experience in the approval of medical devices. For all risk classes from I to III in Europe, USA, Canada, Australia, China.
For your medical device we guarantee
- Safety
through traceable compliance with the requirements of applicable regulations.
- Efficiency
through preconfigured project plans and documents, as well as a redundancy-free document pool with which you can manage your approval in different regions.
We support medical device manufacturers in expanding their portfolio or extending approval to additional regions, updating and implementing new requirements or standards, carrying out gap analyses or making them FDA-ready.
For companies that are not yet active in the medical market or have innovative ideas for medical devices, we also create the conditions for market entry.
This includes the implementation and maintenance of a QM system, the classification of your product and the identification of applicable regulations for the desired regions.
