Translated with AI In September 2025, the Borderline and Classification Working Group (BCWG), an advisory group established by the European [...]
Translated with AI On September 5, 2025, the MHRA (Medicines and Healthcare products Regulatory Agency) published new guidelines and a [...]
Translated with AI Regulatory cooperation initiatives are intensifying in East and Southeast Asia, aiming to streamline medical device evaluation processes [...]
Translated with AI Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection against [...]
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for manufacturers." [...]
Translated with AI On July 21, 2025, the Italian Ministry of Health published new Guidelines on medical advertising for Medical Devices, [...]
Translated with AI The Team-NB, the European association of Notified Bodies for Medical Devices, published the second version of its Position [...]
Translated with AI Following the non-extension of the Mutual Recognition Agreement (MRA) with the European Union on May 26, 2021, [...]
According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer [...]
Mexico strengthens its commitment to simplify access to the Medical Devices market. With the publication of Acuerdo nel Diario Oficial de [...]
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