An introduction to IEC 62304 - Software for Active MedTech

In this presentation, Geoff Sizer explains the critical role of software development for Active Medical Devices. In particular we take a close look at the pivotal standard IEC 62304. This standard specifies the requirements for firmware and software in medical devices at every stage of the product's life cycle. Topics to be discussed: Software development planning Requirements Analysis Architectural Design Detailed Design Software unit implementation and verification Integration and integration testing System testing Software risk management Software release Software maintenance Software validation Geoff Sizer is the CEO of Genesys Electronics Design and ISO 13485 certified contract designer of medical devices.