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NEWS
NEW (Marzo 2023):
Regolamento (UE) 2023/607-amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for
certain medical devices and in vitro diagnostic medical devices
NEW (Marzo 2023): Sicurezza funzionale dei dispositivi medici attivi/UPDATE
NEW (Maggio 2023): Cybersecurity per i dispositivi medici attivi/UPDATE
(Agosto 2022): Contract QARA Manager/Person responsible for regulatory compliance(MDR, art.15) /UPDATE
(Agosto 2022): QS Stress Test
(Aprile 2021):Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE(ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS
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Quadrifoglio Engineering Studio has been active for 20 years in the medical device sector providing consultancy, in particular for medical electrical equipment, Medical Software (CYBERSECURITY, A.I., included), Usability, Product registrations (FDA,JAPAN,CANADA,BRASILE,Other), Quality System (ISO 13485, MDSAP scheme) and product (CE MDR, NRTL, INMETRO) certification. We can be your partner for the design and production processes suitable for the realization of Medical Electrical Equipment and Medical software, Education.
Furthermore, the regulatory requirements that become more and more complex day by day and the more demanding requests of the market impose simplified organizational models: the "SIMPLIMO" model that we have created is the right answer for small and medium-sized companies in the medical sector..
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