This IEC 62304 training gives medical-device engineers a practical understanding of the software lifecycle required for safe, regulated medical device software.
What the IEC 62304 training covers
The course covers the IEC 62304 software development and maintenance processes, software safety classification (Class A, B, C), software risk management in conjunction with ISO 14971, architecture and detailed design requirements, verification and testing, configuration and problem management, and the handling of software of unknown provenance (SOUP).
Who should attend
Medical-device software and systems engineers, quality and regulatory staff, and project leads developing or auditing software under IEC 62304.
What you will learn
By the end, participants can classify software safety classes, structure the lifecycle and documentation IEC 62304 requires, manage SOUP, and link software work to risk management.
Format and delivery
This course is delivered on-site or remotely by ISIT engineers and can be tailored to your team’s protocols, standards and experience level. Contact us to build a programme around your project.