Who Are We
We are a multidisciplined team from diverse cultures that share a passion for health technology.
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
CO-Founder, Managing Director, R&D and Production
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.