Make your product available on your market of interest
We can help you with the registration process and clinical studies needed on every market.
Quality Management system
High quality standards in all our activities
Our GMP-compliant Quality Management System (QMS) is designed to meet the requirements of FDA 21 CFR Part 820 and ISO 13485. We are certified under ISO standards, the MDSAP program, Regulation (EU) 2017/746 (IVDR), and Korean Good Manufacturing Practices (KGMP), among others. Our QMS is regularly audited by notified bodies and certification organizations, and has successfully passed inspections by regulatory authorities worldwide, including the FDA.
Additionally, our quality and regulatory experts actively participate in industry associations, serving on various trade panels to represent and advocate for industry interests.
Regulatory Affairs
Worldwide Expertise in Registration and Compliance
At Werfen, having a global presence is key to our success. We manage regulatory registrations across major markets, including CE marking in Europe and FDA clearance or premarket approval in the United States. We also provide expert support for international registrations around the world.
Over the years, this global experience has given us in-depth knowledge of the regulatory requirements specific to each market.
