Applying IEC 62304

Service Description

LEARNING OBJECTIVES • Understand the main objectives of the IEC 62304 standard. • Understand the link with the other standards and reference documents in the medical device sector. • Understand the requirements of IEC 62304 throughout the software lifecycle. • Understand how risk management fits with the requirements of IEC 62304. Module 1. Regulatory context for medical device software • Applicable regulations. • Evolution of the IEC 62304 standard. • Link with the other harmonized standards. Module 2. General requirements • Quality management system. • Preliminary risk analysis. • Assignment of the software safety class. Module 3. Software development process • Scope of the software development process. • Software development planning. • Software requirements analysis. • Illustration of requirements management and documentation using Jira, Confluence, DMC and PDF Exporter. • Software architectural design. • Illustration of the software architecture using Draw.io. • Detailed software design. • Implementation and verification of software units. • Software integration and integration testing. • Software system testing. • Software release. • Managing unit, integration and system tests, and generating documents (protocols, plans, etc.) via the Xray, Jenkins, JUnit and Jest plug-ins. Module 4. Software maintenance process • Maintenance plan. • Problem and change management. • Setting up maintenance management, change control and problem resolution with Jira Service Management (JSM) and Bitbucket. Module 5. Software risk management • Positioning within overall risk management. • Analysis of software-related hazardous situations. • Risk control measures. • Verification of risk control measures. • Implementing risk management with SoftComply Risk Manager for Confluence. Module 6. Software configuration management • Identifying software configuration items. • Change control. • Using Bitbucket for version management and issue tracking. Module 7. Agile methodology (SCRUM) • Scrum team. • User stories. • Sprint and Backlog. • Version and Release. • Changes. • Agile deployment of an e-QMS.