¿Tienes dudas sobre la regulación de los Medical Devices? Apúntate a la VIII edición de “Breakfast & Learn” organizada por TECSAM.
¿Cuándo? 📆 1 de junio 🕘9:00 horas 💻 Online
Talyta Carteano, Medical Device Associate Director y Lead Auditor de Asphalion, ofrecerá su visión como experta sobre la regulación que requieren estas tecnologías: normativa de fabricación, procesos regulatorios, trámites, ensayos, licencias, entre otros.
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EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices.
Article 17 of Regulation (EU) 2017/745 (Medical Device Regulation – MDR) regulates the reprocessing of single-use devices (SUDs) with relevance for the European Economic Area (EEA) which may only take place where permitted by national law and in accordance with this article.
The AI Act (AIA) is the EU’s first attempt to create a comprehensive AI regulatory framework and aims to ensure the protection of fundamental rights in this field. AI applications used in healthcare are often ‘medical devices’ and are thus regulated under the EU Medical Devices Regulation (MDR).
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