IEC 62304 standard; It defines software as a medical device (SaMD - Software As Medical Device) or software in a medical device (SiMD Software In Medical Device) life cycle processes. This standard is the internationally accepted standard that provides a framework for the development, testing and maintenance of software. It is a fundamental standard, especially considering the development of new software-based technologies in the medical device world.

The purpose of this standard; is to ensure that software is implemented securely, is fully functional, and maintains its security and performance throughout its lifecycle after it is released to the market.

This course aims to provide an overview of the application of IEC 62304 for the development of software as a medical device. The regulatory context, the integration of software features into a medical device will be reviewed and all aspects of IEC 62304 will be presented to be able to implement a compliant software development process.

Exhibitor Profile

• Design and software engineers to understand IEC 62304 expectations regarding the development process
• Team leaders and product managers to understand how IEC 62304 related requirements affect design teams

What will I learn?

• IEC 62304 scope and structure
• Review of the standard requirement
• Classification of your medical device software according to the 2017/745 MDR directive
• Software risk analysis
• Cyber security and medical device software