Software for medical devices

The majority of medical devices used today contain software in some form. This in turn places various requirements on the software, regulated in standard IEC 62304. RISE can assist in evaluating that the requirements of this standard are met.

Purpose

IEC 62304 contains processes, activities and tasks that together create a common framework, necessary for medical device software to maintain an acceptable quality throughout the life cycle of the medical device.

The standard is relevant to the development and maintenance of medical software when the software itself is a medical device or when the software is an embedded or integral part of the final medical device.

This standard does not cover validation and final release of the medical device, even if the medical device consists entirely of software.

RISE can assist in evaluating that the requirements of this standard are met. The reason for taking help from RISE can be both to get help from us to build up your internal competence in the area or that you have a customer who requires you to be able to show that an independent organisation has evaluated your product's software.

By taking help from RISE early in your product development, you avoid the risk of interpreting these frameworks incorrectly.

Method

The evaluation is based on our Swedac accredited methods for:

IEC 62304:2006 / AMD1:2015, “Medical device software”
IEC 82304-1:2016, “General requirements for product safety”. (For products used without dedicated hardware