Expertise

Expertise - Experience Counts

Our profound knowledge in regulatory affairs of medical devices and IVD is the capital we are working with. In summary, our knowledge reflects the expertise needed to support your project in an objective driven, pragmatic way:

• Regulatory affairs managers in medical device / IVD industry
• Notified Body auditors
• Skilled in communication with authorities
• Scientific background

We have successfully supported:

• National and international clients of all sizes – from start-ups, academia spin-offs, medium-sized enterprises up to large corporate groups
• A broad spectrum of medical fields and product categories

Our reliable expertise results in a high level of customer satisfaction: more than 50% of our business is from new projects with repeat clients.