Software for medical devices - IEC 62304 and IEC 82304

The IEC 62304 standard is relevant for the development and maintenance of medical software when the software itself is a medical device or when the software is an embedded or integrated part of the final medical device. The course covers the processes, activities and tasks in the standard that you must take into account to ensure that the software in medical devices maintains acceptable quality throughout the entire life cycle of the medical device.

Purpose

The aim of the course is to give participants a better understanding of the framework of the standard in relation to software in medical devices.

Course content

We will go through two standards during the course. IEC 62304, which mainly concerns products where the software is embedded in a medical device (hardware). IEC 82304, which mainly concerns products where the software is a standalone product, in other words products that are used without any dedicated hardware.

Target group

Project managers and engineers, both in development and maintenance operations

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