Translated with A.I. For Medical Devices and in vitro diagnostic Medical Devices, cybersecurity is essential to satisfy the General Safety [...]
The new Quality Management System Regulation (QMSR) comes into effect on February 2, 2026, following the publication of the Final Rule [...]
Translated with AI On August 29, 2025, the European Commission published Revision 3 of the document "MDR - Language Requirements for manufacturers." [...]
According to MDR (EU) Regulation 2017/745, IVDR (EU) 2017/746 and ISO 20417, printed matter comprises all information provided by the manufacturer [...]
Thema srl
Via Saragat, 5
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Tel. +39 0542 643496
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Thema Corp
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