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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
FAQ
What is a regulatory strategy
How do I register medical devices in the world
Why is the CE marking required
What are the GMP requirements
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News
- 27 March 2020 The Medical Device Coordination Group (MDCG) approved the guideline on significant changes required by article 120 of the MDR concerning the Period of Grace MDD or AIMDD certificates. MDCG guideline ...
- 27 March 2020 Because of the virus COVID-19, FDA is postponing the majority of foreign inspections to a later date, exception made for those considered “mission-critical”, that will be considered case by case. Because ...
- 27 March 2020 To reinforce the regulations on medical devices in India, the Central Drugs Standard Control Organization (CDSCO) published two amendments to the 2017 medical device regulation. Both amendments will enter into force from April 1, ...
- 24 March 2020 THEMA continues to carry on all work activities without any interruption or variation, respecting the new rules and restrictions in compliance with the Italian Government Decree published last March 22, ...
- 17 March 2020 Manufacturers, Authorised Representatives, Importers, and Distributorsof medical devices may not have yet fulfilled the obligations required by the MDR (EU) 2017/745 for Economic Operators. It could be hard to keep the ...
- 19 February 2020 The new nomenclature to use during the medical devices registration in EUDAMED database will be called “European Medical Device Nomenclature” (EMDN). The criteria for the future EMDN for the EUDAMED nomenclature have ...
- 19 February 2020 The new ISO 10993-18: 2020 Medical devices biological evaluation – Part 18: Medical devices materials chemical characterization as part of a risk management process standard has been published. New ISO 10993-18:2020 ...
- 19 February 2020 South Korea’s Ministry of Food and Drug Safety (MFDS) emitted two regulatory provisions on medical devices. These two provisions entered into force in their final version on January, 17 2020 ...
- 22 January 2020 The Uniform Recall Procedure for Therapeutic Goods (URPTG) is updated by Australian Therapeutic Goods Administration (TGA). The aim of this procedure is to assist Sponsors in leading recall and non-recall actions ...
- 22 January 2020 On January 15, 2020 the FDA Guidance “Medical Device Submissions: Amending Premarket Regulations That Require Multiple Copies and Specify Paper Copies To Be Required in Electronic Format” came into force, amending ...