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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

  • 12 December 2018

    SINGAPORE: increased regulatory fees starting April 2019

    Starting April 2, 2019, the Singapore Regulatory Authority, Health Sciences Authority (HSA), will apply a 3% increase in fees for regulatory activities required by medical devices. Mostly unchanged since 2006, the fees ...
  • 12 December 2018

    AUSTRALIA: new requirements for implantable medical devices

    With the intention of aligning the TGA (Therapeutic Goods Administration) regulations with the European MDR (EU) 2017/745, starting December 1, 2018, the Australian government will require that some active implantable ...
  • 12 December 2018

    EUROPEAN UNION: updated borderline device manual

    Published on October 30, 2018 by the European Commission, the latest version of the “Manual on borderline and classification in the community regulatory framework for medical devices” shows through six ...
  • 14 November 2018

    SOUTH KOREA: Harmonizing KGMPs to ISO 13485:2016

    Aiming to harmonize the Korean Good Manufacturing Practice (KGMP) with the requirements of the ISO 13485: 2016 Standard, the South Korean Ministry of Food and Drug Safety (MFDS) issued on ...
  • 14 November 2018

    USA: Medical devices cybersecurity Guidance update

    To allow a more efficient pre-market review process and more effective protection of marketed medical devices against cybersecurity vulnerabilities, FDA issued on October 18 the draft of the latest edition ...
  • 14 November 2018

    EUROPEAN UNION: five guidelines on UDI implementation

      Published on October 10, 2018 by the Medical Devices Coordination Group (MDCG), five guidelines provide insights on the implementation of the UDI (Unique Device Identification) in accordance with the MDR ...
  • 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

    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

    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 ...

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