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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

  • 17 October 2018

    INDIA: Operational guidance for medical devices and IVDs

    Guidance for medical devices (MDs) To support all the stakeholders in the implementation of the Regulation on Medical Devices 2017 , which came into force last January, CDSCO (Central Drugs Standard ...
  • 17 October 2018

    RUSSIA: Guidance for the registration of software as medical device

    Last September 2018, the Russian Regulatory Authority Roszdravnadzor published the  “Methodical recommendations on the order of examination of the quality, efficiency and safety of medical devices (in terms of software) for ...
  • 17 October 2018

    USA: Quality in 510(k) “Quik” Review Program Pilot

    With the intention of facilitating the placing on the market of safe, effective and high quality medical devices, last September 2018, FDA launched a new program pilot entitled Quality in ...
  • 27 September 2018

    EGYPT: changes to the registration procedure

    In August 2018, the Egyptian Regulatory Authority announced the extension of registration requirements for the placing of medical devices on the territory. Prior to this communication, only Class III devices, ...
  • 27 September 2018

    ISO: ISO 10993-1:2018 publication

    Last August, the 2018 version of the ISO 10993-1 Standard “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” was published. The new version ...
  • 27 September 2018

    CANADA: MDAL renewal by November 1st

    The deadline for the Medical Device Active License (MDAL) renewal in Canada is approaching. In compliance with clause 43(1) of the Canadian MDR SOR 98/282, in fact, by November 1st of each ...
  • 8 August 2018

    USA: Annual Report 2018 to the CDRH

    As each year, between July 1 and September 1, 2018 manufacturers of medical devices emitting radiation are required to submit the Annual Report to the CDRH (Center for Devices and Radiological ...
  • 8 August 2018

    USA: FDA 2019 user fees update

    The FDA announced the updated fees for the fiscal year 2018/2019 that will come into force starting from October 1, 2018 and will be valid until September 30, 2019. More specifically: Establishment ...
  • 8 August 2018

    EU: Useful instructions for MDs and IVDs manufacturers

    If you are a manufacturer, an Authorized Representative, an importer or distributor, you will most likely receive further instructions from the European Union on the implementation of the MDR (EU) ...
  • 19 July 2018

    USA: ANSI/UL 2900-2-1 and ISO 18562 officially recognized

          Among the modifications of the recognized Standards list, which were published on June 7 by the FDA, the recognition of ANSI / UL 2900-2-1 (section: software, cyber-security) and ISO 18562 ...

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