Make your product available on your market of interest
We can help you with the registration process and clinical studies needed on every market.
Worldwide expertise in registration
For Werfen, having a global presence is key. We can handle registrations in Europe (CE marking) and the USA (FDA), as well as providing support in international registrations worldwide. Across the years, this experience has given us extensive knowledge of the requirements in each market.
Our GMP-compliant Quality System is designed to meet FDA 21 CFR 820 and ISO 13485 requirements and we are certified both under ISO as well as under the MDSAP program. Our QMS is regularly audited by notified and certification bodies, and has been successfully inspected by worldwide agencies, including FDA. Furthermore, our quality and regulatory expert staff sits on several trade panels of relevant associations to represent industry interests.