In order to foray into the Romania medical device market, seek expert help and medical device registration services from Arazy Group, a leading name in medical device consultancy. We offer the best of medical device regulatory services from document preparation and technical documentation to a wide range of authorized representation services at the medical device regulatory bodies in Romania. We offer you to fulfill the different CE marking requirements in Romania for your medical devices, equipment, IVDs etc.

Some of our prime medical device regulatory and medical device consultancy services for manufacturers and marketers in Romania include:

-          Medical Device specific CE Mark regulation strategy reports

-          CE Mark Registration of all Medical Devices, IVDs and Active implant medical devices

-          Technical File and Design Dossier preparation

-          ISO13485 establishment and implementation

-          Product validation consultation

-          EU Authorized Representative services

-          Clinical Research planning and management

For more information on our medical device consultants and regulatory services in Romania, feel free to contact us today!

(Fill out our enquiry form on the website and reach us instantly or chat with us on our site)