Thema’s experts follow the complex changes in the regulatory environment and guide you through the transformations required to successfully operate in the field of Medical Devices and In Vitro-Diagnostic Medical Devices.

Thema’s experts guide and support Manufacturers in the process of obtaining CE marking for Medical Devices and IVDs produced (Ref. MDR (EU) 2017/745) and IVDs (Ref. IVDR (EU) 2017/746).

Thema’s experts perform all preparation and support activities for the registration of in-vitro medical and diagnostic Medical Devices with the European Competent Authorities, including the Italian one.

Thanks to partner agencies in more than 20 non-European countries, Thema performs preparation and support activities for the registration of in-vitro medical and diagnostic devices with foreign regulatory authorities.

Thema’s experts comprehensively assist you in the implementation of the Quality System for Medical Devices and Good Manufacturing Practice (GMP), in accordance with the requirements set by the regulations of the target country.

Thema’s experts ensure full control of your recordings, making you independent of your distributors.

MD24 is the brand dedicated to the valuable training of professionals working in Quality&Regulatory Affairs in the field of Medical Devices and In Vitro Diagnostics.

MDG – MedGenerAction is the Italian annual summit for Professionals dealing with Regulatory Activities applied to Medical Devices.