This online course focuses on the process of developing software for medical devices. This includes topics such as how to efficiently plan and document software development, getting requirements right, how to approach software architecture and software risk management, how to perform software safety classification correctly and working with SOUP/OTS software. The course covers all aspects of the IEC 62304 standard and the relationship between the IEC 62304 and other standards such as ISO 14971, IEC 60601-1 and IEC 82304–1.
The course include free templates for all required documents, checklist required for showing compliance to the standard and comparison matrix to the FDA standards for developing software in medical device.
Recommended for software managers, software developers, software testers, product managers, regulatory affairs personnel, and quality assurance engineers.
How to use this course
Why Medical Device software is different
IEC 62304 Introduction
IEC 62304 Medical Device Software Life Cycle Processes
IEC 62304 General Requirements
IEC 62304 Software Development Process - Planning and Requirements Analysis
IEC 62304 Software Development Process - Architecture, Detailed Design, Implementation, and Unit Verification
IEC 62304 Software Development Process - Integration Testing and System Testing
IEC 62304 Software Release, Configuration Management Process
IEC 62304 Software Maintenance Process
IEC 62304 Software Problem Resolution Process
IEC 62304 Introduction to Risk Management
IEC 62304 Software Risk Management Process
Off-The-Shelf Software Use in Medical Device - IEC 62304 SOUP
