Amstermed was founded in Amsterdam with a clear mission: to bring structure, transparency, and expertise to the complex world of healthcare regulatory compliance. What began as a European-focused consultancy has evolved into a truly global practice spanning five continents.

Our founders — regulatory scientists and medical device engineers — recognized that manufacturers needed more than just submission support. They needed a strategic partner who understood the interconnections between regulatory systems and could navigate them simultaneously.

Today, Amstermed operates from five offices across London, Amsterdam, Zurich, Sydney, and Boston, with a team of over 40 regulatory professionals who have collectively contributed to more than 500 successful device approvals.