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Usability and Labelling

What is usability ?   The new Regulation, MDR, strengthens the rules regarding labelling and usability.   Usability is the characteristic of the user interface that facilitates use and establishes effectiveness, efficiency and user satisfaction in the intended use...

Electrical Safety and EMC 60601

IEC 60601: Safety and effectiveness of medical electrical equipment. This standard specifies general requirements for basic safety and essential performance. Collateral standards apply the 60601-1-3 standard states for radiation protection in diagnostic X-ray...

How to conduct a Software Risk Assessment

First, the risk must be identified. It is always the same scheme; a hazard combined with a hazardous situation can lead to harm. All factors must be determined before the hazard occurs. Risks combine the severity of harm (S) and the probability of occurrence(O). A...

What is Software of an Unknown Provenance known as SOUP?

International standard IEC 62304 defines life cycle requirements for the development of medical software inside medical devices. This regulation is harmonized by the European Union and the United States and thereby serves as a standard by which to...
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