Software Safety Classification Template (IEC 62304, Medical Device)

Description

Why it is useful

Software safety classification, SSC, is essential for establishing an appropriate process rigour when developing medical device software.

The standard IEC 62304 does not require specific software safety classification documentation. It suffices with a documented statement concluding your stance on the classification. However, from to time, the classification might be challenged, both internally and externally. It is helpful to have a solid rationale for the classification documented when it happens.

Furthermore, when outsourcing software development, it can be wise to own the software safety classification and use it as guidance to control the relationship with an external vendor.

This template provides a pathway to capture the rationale behind your conclusion about the determined software safety classification.

How to use it

1. If you are developing brand-new software, the assumption should be that the software is class C (the highest), until you have proven that it is a lower class. Initiate the software safety classification early to avoid meeting requirements that apply to higher classes of software than necessary.
2. In mature projects, re-evaluate the software safety classification whenever there are significant changes to the:

1. 1. 1. risk management file, or
      2. software requirements

In this template, instructions and/or explanations are included using blue italic texts such as these. Instructions and explanations should be removed before using the document. All texts that are not blue are example texts that can and should be edited by you. Texts that most certainly should be replaced or updated are identified by the { and } characters. They should be removed, and the example text customized to work with the current project.

Support

If you have questions about the content of the template, you may ask questions in the support forum up to 10 days after your purchase. The support forum is accessible on this link when you are logged into your account. You can see other previously asked questions as well as ask any question you may have.

Need medical software development training and a course certificate?

If you should want to know more about medical device software development and IEC 62304, the topic is covered in our public training courses: Introduction to Software for Medical Devices and IEC 62304, Introduction to SaMD, IEC 62304 and IEC 82304-1, and Software for Medical Devices and IEC 62304 blended course. Our blended courses combine a self-paced online course first, followed by a live virtual classroom session facilitated by an industry expert.