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October 21, 2025

ASCA: Accreditation Scheme for Conformity Assessment

By Mario KlessascheckOctober 21, 20252 Comments

ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works.

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What the AI Act means for medical device and IVD manufacturers

By Prof. Dr. Christian JohnerOctober 21, 2025Leave a comment

The EU AI Act has been published. Many manufacturers of medical devices and IVD, as well as other healthcare players, are faced with the major task of understanding the 140+ pages of legal text and complying with the requirements. Note: Infringements/violations of the AI Act are punishable by a fine of up to 7% of…

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