It is with great pride and satisfaction that we announce that THEMA is joining to the international Organization RAPS - Regulatory [...]
Following the failure to achieve an institutional agreement between Switzerland and the European Union, Switzerland made the CH REP nominee [...]
In the field of medical and in vitro diagnostic devices, being familiar with acronyms and most used definitions regarding Regulatory Activities [...]
In June 2021 the Medical Device Coordination Group (MDCG) published on the website of the European Commission the IVDR Preparation and [...]
The regulatory regimes of the Old Continent are undergoing great change: the scenario is fairly heterogeneous and far from a standardization [...]
UPDATE 31/05/2021 Since 26 May 2021, with the full application of the Medical Device Regulation MDR (EU) 2017/745 and in the [...]
In the United States, according to the Medical Device Reporting: Electronic Submission Requirements (eMDR), the Food and Drug Administration (FDA) requires [...]
Great satisfaction for the 1st MDR Certificate obtained by 3DIEMME with Thema support With great pride and satisfaction, we communicate that [...]
Discover Thema services to reach your objectives in time! Impending deadlines: what do you need right now? The regulation of Medical [...]
Short time to May 26, 2021 which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017/745. [...]
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