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THEMA offers strategic and regulatory consulting to medical device IVDs and regulatory-related companies.

THEMA aims to help the Customer to achieve his own commercial purposes, using a reliable and competent regulatory specialist partner.

THEMA supports national and foreign companies with needs, projects, possibilities and different aims that want to place their devices on national and international markets in compliance with regulations.

Our team has the required professional skills and competencies to perfectly understand Customer’s needs, products and services, by acting quickly and in the most suitable manner.

Our branches and international partners collaborate with us to find out the solution that best suits Customer’s specific needs, protecting even his interests.




  • 8 August 2017

    INDIA: A growing market opportunity and regulation

    Read our White Paper INDIA: A growing market opportunity and regulation and you will understand: Medical device market in India ; Opportunities to do business in the country; 5 rules for doing business ...
  • 3 August 2017

    About the 60601-1-2

    Electromedical device manufacturers have been dealing for some time with issues related to the electromagnetic compatibility of electromedical equipment and systems, both regarding the disturbances emitted and the ability to ...
  • 27 July 2017

    Clinical Evaluation: an integrated approach

    Read our White Paper CLINICAL EVALUATION: AN INTEGRATED APPROACH and you will understand: The clinical evaluation according to MEDDEV 2.7/1 rev.4; The clinical evaluation according to the New Regulation (MDR); Notified Bodies possible approach. Fill in ...
  • 26 July 2017

    RUSSIA: registering a medical device in 5 steps

    In these economic times where internationalization is a survival need for Italian companies, it is natural to focus on the most interesting and potentially profitable markets. An initial evaluation is ...
  • 25 July 2017

    Conforming with ISO 13485:2016

    Read our White Paper CONFORMING WITH ISO 13485:2016 and you will understand: What has changed in the new ISO 13485:2016; The new requirements; How the ISO 13485 and the ISO 9001 differ. Fill in the form ...
  • 24 July 2017

    RUSSIA: the Eurasian harmonized regulatory system almost real

    Armenia, Belarus, Kazakhstan, Kyrgyzstan and Russia have already signed an Agreement in order to establish a harmonized regulatory system for medical devices across Eurasian Economic Union (EEC). Last March, a session ...
  • 24 July 2017

    CANADA: postponed the deadline for Reprocessed Medical Devices

    Health Canada (HC) postponed the deadline to license Reprocessed Medical Devices by a MDAL (Medical Device Application License) or a MDEL (Medical Device Establishment License) to September 1, 2017. The new ...
  • 24 July 2017

    USA: updated the post-market surveillance guideline for class 2 and class 3 devices

    On May 16, 2016 the FDA published the updated guideline “Postmarket Surveillance under section 522 of the Food, Drug and Cosmetic Act”. This guidance is applicable when FDA officially orders to ...
  • 24 July 2017

    USA: submission of the Annual Report 2016 to CDRH

    For radiation-emitting devices, the manufacturers shall submit to CDRH (Center for Devices and Radiological Health) an Annual Report including information about the devices manufactured, sold and installed in the territory ...
  • 24 July 2017

    USA: are you confident about your Initial Importer?

    The new year has begun, and your 2017 FDA Establishment Registration has been renewed. Every foreign manufacturer selling medical devices in the USA, after obtaining product registration, must register his plant ...