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Software Development for Medical Device Manufacturers

Newly updated in 2025 to help your organization prepare for new FDA QMSR + ISO 13485

Compliance required Feb 2026

The regulatory landscape for medical device software development is changing dramatically. Beginning in February 2026, device manufacturers must comply with the new FDA Quality Management System Regulation (QMSR) which is based on the ISO 13485 Medical Device Quality Management System Standard. In addition, a recently adopted standard for security risk management (AAMI SW96) adds additional requirements for cybersecurity. This course provides insight into these changes as well as requirements for safety risk management as defined in ISO-14971 Medical Device Risk Management and IEC-62304 Medical Device Software - Software Life Cycle Process. Also discussed is IEC-62366-1 Medical Devices - Application of Usability Engineering. This course reflects both current FDA regulations as well as the new FDA QMSR + ISO-13485, ISO-14971, IEC-62304,IEC 62366-1 and AAMI SW96.

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