IEC 62304 has introduced the concept of safety classification to allow medical device manufacturers to adapt the effort required for software documentation to the degree of possible harm that a software defect would cause. This article will help you determine the safety classes and document compliant with IEC 62304. Update: No more presumption of conformity…
DetailsThis article describes the requirements of the in vitro diagnostic medical device regulation (IVDR) for software development and documentation. The requirements apply to software that is part of an IVD (embedded software) and to software that is an IVD itself (“standalone” software). This article also compares the software requirements of the MDR and the IVDR.
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