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. This has given us knowledge of the requirements of each market and we have amassed extensive experience on different markets.
Our Quality System is designed to meet FDA 820 and ISO 13485:2016 requirements and we are certified in the latter under the MDSAP program. Our GMP quality system is regularly audited by worldwide agencies and our quality and regulatory staff sit on several trade panels to represent industry interests.
We can handle registrations in Europe (CE marking) and the USA (FDA), as well as provide support in registrations in other countries.
Our Market Surveillance team manages activities in complaints, field actions and vigilance systems.