ENOVA SWISS supports companies in the development and third-party production of medical devices branded for the client, targeting the aesthetic medicine market, and operates in accordance with the Regulation (EU) 2017/745 (MDR) and the production standards for medical products ISO 13485.

What we offer:

• Certified formulations for medical devices of class IIa, IIb, and class III
• Drafting of technical documentation and support for CE marking
• Complete management of the regulatory documentation for EU and non-EU registrations
• Support in audit processes by Regulatory Bodies

Thanks to the cooperation with qualified partner laboratories, ENOVA SWISS guarantees a turnkey service to develop customized medical devices with high standards of quality and compliance.