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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

  • 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 ...
  • 19 July 2018

    RUSSIA: Simplified registration process for MDs and IVDs

    The Russian government issued the Decree No. 633 “On Amending the Rules for the State Registration of Medical Products”, implementing long-awaited changes to the registration rules of Russian medical devices. ...
  • 19 July 2018

    UNITED KINGDOM: Stand-alone software and medical applications guidance

    On June 20, 2018 the Medicines & Healthcare products Regulatory Agency (MHRA) published a guidance in order to provide clarifications on which applications and stand-alone software are included in the ...
  • 18 July 2018

    The equipment qualification within software process validation

    Qualification or validation? The process validation represents both the substantial and formal demonstration of the ability of the process to provide (within pre-defined parameters) in a consistent manner results that meet ...
  • 12 July 2018

    SPAIN: CCPS Portal activation

    On June 26, 2018 the Spanish Regulatory Authority AEMPS issued a specific Information Note stating that as of July 4, 2018 a new CCPS Portal (Comunicación de Comercialización de Productos ...
  • 3 July 2018

    MALAYSIA: Medical Device Regulation implementation

    As of July 1, 2018, all medical devices must meet the registration requirements set forth in section 5 of the Medical Device Act 2012 in order to be marketed in ...
  • 3 July 2018

    USA: Medical device QMS soon harmonized

    The FDA has declared its intention to harmonize and modernize 21CFR 820, the regulation of the Quality Management System (QMS) related to medical devices.   The existing Quality System requirements will be ...

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