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    • Market Access
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      • And more…
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      • Quality management systems (ISO 13485)
      • ISO 13485 audits
      • Quality management representative
      • Quality management system as a service
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      • Software (IEC 62304, FDA)
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      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
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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, 20251 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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