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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.




  • 16 October 2017

    Managing the medical documentation

    Read our White Paper Managing the medical documentation and you will understand: the current regulations according to Directive 93/42/EEC; what is the translation validation; What is the traslation accuracy. Fill in the form to ...
  • 10 October 2017

    RUSSIA: restricted access to public contracts for foreign manufacturers

    Resolution No. 967 and Resolution No. 968 have recently entered into force in order to further restrict participation to public contracts for foreign manufacturers, with particular reference to manufacturers of ...
  • 6 October 2017

    What is ASEAN?

    Look at our video to know how much progress has been made towards ASEAN Medical Device Directive. https://www.youtube.com/watch?v=8FJHIWUQCqE Download the whitepaper “What is ASEAN?”
  • 2 October 2017

    CANADA: are you ready for the MDSAP?

    As of January 1, 2019, according to the Canadian classification system, Class II, III, and IV medical devices manufacturers who intend to market their products in Canada will have to ...
  • 26 September 2017

    USA: FDA introduces Small Business accreditation web page

    The Center for Devices and Radiological Health (CDRH) provided its users with a web page including all the useful information for companies on the “Small Business” program. Through the “Small ...
  • 19 September 2017

    FRANCE: mandatory notification for Class III and implantable medical devices

    Decree No. 2016-1716, which sets out the information to be submitted to the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) when notifying Class III and ...
  • 15 September 2017

    What is ASEAN?

    Read our White Paper What is ASEAN? and you will understand: what is the Association of Southeast Asian Nations; what is the ASEAN Directive; where we are now. Fill in the form to receive by ...
  • 13 September 2017

    USA: news from the FDA world

    United States remains an interesting market with a great potential for the medical sector. The latest data are still in line with a well-tested trend: the country is the world’s largest ...
  • 11 September 2017

    INDIA: a growing market opportunity and regulation

    Look at our video to have more info about the medical devices market in India, the opportunities and the incomincia Regulation. https://www.youtube.com/watch?v=lIRJU2V_kQc Download the whitepaper “INDIA: a growing market opportunity and regulation”
  • 7 September 2017

    INDIA: measures in preparation for the Medical Device Rules 2017 were approved

    In view of the new Medical Device Rules 2017 entry into force, two measures were recently approved in India relating to: the list of medical devices and IVDs subject to registration; ...