Safely through the regulatory jungle .
So that your innovations do not burst before they reach the market.
We are not “THE CONSULTANTS”, but engineers, clinical and regulatory experts as well as quality managers whose profound expertise is based on a multitude of international development, manufacturing and approval projects of medical devices.
Our clients – start-ups, small or medium-sized companies as well as corporate groups – benefit from this expertise when it comes to advisory and executive support
- on all regulatory topics accompanying development,
- the preparation of technical documentation
- clinical or performance evaluations and studies,
- on European and international marketing authorisations,
- on corporate processes and certifications,
- for the assumption of regulatory roles (manufacturer, authorised representative),
- in the digitalisation of your documentation and processes.