About Us

Who Are We

We are a multidisciplined team from diverse cultures that share a passion for health technology.

Our Mission

To help small and new medical device companies traverse the quality and regulatory landscape to successfully meet market needs and requirements.

What We Do

We step in to speed up the process of launching your product on the market.

Meet the team

DAN NEGREA

CO-Founder, Managing Director, R&D and Production

WOLFGANG WERNER

CO-Founder, Managing Director, RA and QM

Dr. CATHARINA POULET

Director, Regulatory Affairs and Quality Management

Why choose us?

Whether you are a start-up with a tight budget or an established company, we tailor and execute a strategy that’s right for your needs.

Save time to market  by getting the help you need. Our team is dedicated to support you with the Quality and Regulatory Expertise that we master, so that you can fully focus on and commit to your core mission

We support your project to market entry, and if you are satisfied with our services we are happy to continue to maintain your quality system, take care of your post market surveillance activities, and manage your audits.