IEC 62304:2006/AMD1:2015 — Medical device software — Software life cycle processes

Defines the life cycle requirements for the development and maintenance of medical device software. IEC 62304 specifies software development planning, requirements analysis, architectural design, detailed design, unit implementation, integration, verification, and maintenance processes. Applies a risk-based approach with three software safety classes (A, B, C). Required by the EU MDR/IVDR, FDA, and most international regulatory frameworks for any medical device containing software.

Standard Details

• Standard Number: IEC 62304:2006+AMD1:2015
• Type: IEC Standard
• Published by: IEC
• Official Link: https://webstore.iec.ch/en/publication/22794

This standard is referenced in the harmonized standards lists for the EU Medical Device Regulation (MDR) 2017/745, EU In Vitro Diagnostic Regulation (IVDR) 2017/746, and is recognized by regulatory authorities worldwide including the FDA, Health Canada, and TGA.