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    • Market Access
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      • And more…
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      • Quality management system as a service
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      • Clinical Evaluation
      • Performance evaluation of IVDs
      • Electrical Safety & IEC 60601
      • Human Factors / Usability (IEC 62366 and FDA)
      • FDA relevant documents
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      • Human Factors Research
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      • Seminar Overview
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      • Current Vacancies
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March 26, 2024


Risk management in hospitals and at other operators

By Christian RosenzweigMarch 26, 2024Leave a comment

Laws require risk management in hospitals, especially in order to improve patient safety. Nevertheless, many hospitals find this difficult. This article presents the most important regulatory requirements and provides tips for implementation.

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Qualification and classification of IVD software

By Dr. Tina PriewasserMarch 26, 2024Leave a comment

The qualification and classification of IVD software determine how and how quickly IVD manufacturers can bring their software to market and what costs arise for “approval.” This article will help you correctly qualify and classify IVD software, thereby avoiding regulatory problems and the resulting costs and delays.

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The FDA’s cybersecurity guidance documents

By Christian RosenzweigMarch 26, 2024Leave a comment

Medical device cybersecurity is a focus not only for the FDA but also for other legislators and authorities, both in the US and other markets. This is understandable The USA has added requirements for cyber devices to the Food, Drug & Cosmetic Act (FD&C), and the FDA has published several guidance documents on cybersecurity, which…

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