Case Study: Sony achieves ISO 13485 and IEC 62304 compliance with Aligned Elements

Sony - Customer Case Study

Sony Network Communications Europe used Aligned Elements to help make its mSafety platform ready for medical regulatory standards such as ISO 13485 and IEC 62304. The team needed a tool that could support quality and lifecycle requirements, improve documentation, and create the traceability needed for customers to certify medical applications built on the platform.

With Aligned Elements, Sony was able to manage requirements, create output documents, and maintain traceable documentation through the full lifecycle. Aligned Elements supported design control, versioning, and tracing of software and risk-related items, helping Sony work toward compliance and reduce barriers for customers adopting mSafety for regulated medical use.

Sony

Claes Nilsson

Master System Engineer