About us

About Medical Devices Regulatory unit

The Medical Devices Regulatory unit, from Instituto Pedro Nunes, is composed of experienced and dedicated professionals who specialise in the different areas of the regulatory context, focusing exclusively on the Medical Devices, Software as a Medical Device and in vitro Diagnostic Medical Devices sectors.

With a proven track record in diverse markets, including Europe, the United States of America, the United Kingdom, Brazil and Latin America, we are committed to helping our customers achieve the highest standards of quality, safety and compliance, while simultaneously stimulating innovation and growth in the medical device sectors.

Our approach is powered by our experience in Cybersecurity, Artificial Intelligence and Robotics, which, complemented by our engineering team, allows us to offer detailed support to MedTech, Digital Health and Software as a Medical Device companies.

We are dedicated to providing personalized solutions and strategic approaches to meet the complex challenges faced by growing companies in the medical devices and in vitro diagnostics sectors.

Join us on this journey towards excellence and innovation in the healthcare sector.

As experts in the regulatory field, our team is ready to become your trusted partner in achieving excellence and innovation in the medical device, software as a medical device and in vitro diagnostics sectors!

Meet the team

Sandra Balseiro

Head of Medical Devices Regulatory unit

Ana Brito

FDA and QMS Expert

Celeste Oliveira

CE Marking and QMS Expert