Glossary · Regulation
ISO 13485
Medical devices, quality management systems
ISO 13485 is the quality management system standard for organisations that design, produce or service medical devices, aligned with the MDR's QMS requirements.
A SaMD manufacturer typically certifies to it alongside IEC 62304 for the software process.
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Definitions written by Anpheros from the official sources linked on each page. General information about standards and regulation, not legal or medical advice. All terms →