IEC 61010-1 and IEC 61010-2-101: Requirements for IVD medical devices

The IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…

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ISO 19011: Audit management for medical device manufacturers under the MDR

ISO 19011 is the international guideline for auditing management systems. Therefore, your notified body considers ISO 19011 state-of-the-art when it checks during your ISO 13485 certification audit whether you are conducting your internal and supplier audits effectively. Consequently, those responsible for quality management, in particular, should be familiar with and consider ISO 19011. This article…

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C5 certificates also for medical device manufacturers?

C5 certificates are relevant for service providers and, where applicable, for medical device manufacturers. The German Digital Act (DigiG), which came into force at the beginning of 2024, redefines the requirements for cloud services in the healthcare sector. This article explains the most important aspects of C5 certification for medical device manufacturers and service providers…

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