EAA Med Consulting is a consultancy specialized in medical devices, supporting manufacturers, startups, and healthcare companies throughout the entire product lifecycle. We help transform innovative ideas into compliant medical devices ready to enter international markets.
Our expertise includes regulatory strategy, technical documentation under the European Medical Device Regulation (EU) 2017/745 (MDR), ISO 13485 quality management systems, ISO 14971 risk management, clinical evaluation, usability engineering, Software as a Medical Device (SaMD), cybersecurity, and compliance with international standards. We also support companies in defining regulatory pathways for both the European and U.S. markets.
We work closely with organizations of all sizes, from startups developing their first medical device to established manufacturers seeking additional regulatory or quality expertise. Our goal goes beyond compliance, we help companies use regulatory strategy as a business enabler, reducing development risks and accelerating market access.
