COURSES | Asphalion Knowledge Centre

January 9, 2024

Welcome to Asphalion Knowledge Centre, a training platform for Biotech, Pharma and MedTech professionals. Our platform offers specialized courses taught by expert trainers familiar with EU and US regulations, ensuring a relevant learning experience.

Check out the courses coming up in February!

27+28- Internal Auditors ISO 13485: Unlock ISO 13485:2016 auditing expertise. Master compliance, audit essentials, and boost your medical device quality management skills.

29/2+ 7/3 -Key points in the elaboration of PSURS for medicinal products and medical devices. Master the art of PSURs: Unveil the safety and efficacy of medical products through expert-led analysis and risk assessment.

Early bird! Register at least 30 days before course start and get 10% off.


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NEWS | New Insight on the Implementation of MDR Article 17

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 European Union’s AI Act & its Impact on Medical Devices

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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