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Mission

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.

Mission

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News

  • 11 December 2017

    CANADA: amendments to SOR 98/282 came into force

    Amendments to the Medical Devices Regulations (SOR 98/282) of February 13, 2017 made by the Canadian Regulatory Authority, Health Canada, recently came into force. Substantive amendments concern the “safety and efficacy ...
  • 11 December 2017

    CHINA: the acceptance criteria on overseas clinical data were published

    On October 31, 2017, the Chinese Regulatory Authority, CFDA, updated the list of medical devices exempt from on-site testing. Through Notification No. 170, additional Class II and III devices and in ...
  • 11 December 2017

    EUROPE: the first steps towards the new Regulation implementation

    On November 7, 2017 the CAMD – Competent Authorities for Medical Devices – published the road map for the implementation of the new Regulation. The document identified seven thematic areas and ...
  • 21 November 2017

    The new MD and IVD Regulations: focus on economic operators

    Read our White Paper The new MD and IVD Regulations: focus on economic operators and you will understand: what are the MD and IVD Regulations; what is going to change with the ...
  • 15 November 2017

    CHINA: possible foreign clinical data approval at CFDA

    On October 10, 2017 the CFDA published the “Review and approval system reform and support drug and medical device innovation” draft. With the approval of this draft, manufacturers interested in marketing ...
  • 10 November 2017

    USA: Two guidances on 510(k) procedure were published

    After being draft for months, last October the FDA finally issued two guidances for handling changes to devices registered or notified with the FDA: – “Deciding when to submit a 510(k) ...
  • 7 November 2017

    UNITED KINGDOM: How Brexit is facing the new Regulation

    The British medical devices and IVDs Associations recently published a letter to those involved in Brexit negotiations. The letter aims to highlight the need for joint legislation between the European Union ...
  • 2 November 2017

    The Customer satisfaction

    Look at our video to know more about the Customer satisfaction. https://www.youtube.com/watch?v=hZ4iMjCg37g Read our White Paper The customer satisfaction and you will understand: the customer’s satisfaction degree; ISO 9001; continuous improvement strategy. Fill in the form ...
  • 31 October 2017

    The role of the Responsible Person in the light of the New Regulations

    Regulations 2017/745 on Medical Devices and 2017/746 on In Vitro Diagnostic Medical Devices introduce the Responsible Person role to grant more authority and importance to the Responsible/Regulatory Officer within the ...
  • 26 October 2017

    Managing the medical documentation translation

    Look at our video to know more about managing the medical documentation translation. https://www.youtube.com/watch?v=B73Oa0npl48&t=4s Read our White Paper Managing the medical documentation and you will have more information about: the current regulations according ...

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