Overview
Hardly any other industry is subject to such intensive regulation. The European Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA) impose the strictest requirements on quality, safety, traceability, and risk management throughout the product life cycle of components and assemblies used.
The FMA Group is very familiar with the requirements and quality standards. Our ISO 13485 certification underscores our commitment to the highest quality standards in medical technology. It not only confirms our compliance with international standards, but also guarantees that our manufacturing processes meet the strict requirements for medical devices.
Our internal practice of "manufacturing ownership" further emphasizes this standard, as it ensures a high level of commitment to quality among all of our production employees.
