Use scenario – user story – user task: finally getting the big picture

IEC 62366-1 uses the concept of (hazard-related) use scenario. The FDA recognizes critical (user) tasks. In development, use cases and user stories are used. This variety of terms makes it difficult to achieve a common understanding. However, this is necessary to create a consistent and legally compliant usability engineering file and avoid regulatory problems. This…

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Special authorizations for medical devices: Last resort for manufacturers?

Special authorizations are a concept of the MDR (Article 59). In this way, the legislator wants to create a possibility to place medical devices on the market in emergency or exceptional cases, even without having gone through a complete or successful conformity assessment procedure. Special authorizations should not be confused with concessions and exemptions under…

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