Tag: IEC 62304

The IEC 62304 describes how to develop and document software for medical devices. This page contains all our articles we’ve posted so far on this standard, plus questions we’ve been asked by our consulting clients. Additionally, we publish our IEC 62304 templates for free (yes, seriously) and you can also find those below.

Articles

No image yet.

Questions

Do We Have to Re-Do All Software System Tests After a Minor Change?

Anonymous

updated about 1 year ago

We’ve certified and released the first version of our software as a medical device. Now we’re working on a minor update which just fixes some bugs. Do we have to re-do all our software system tests be

Accepted answer

No, not necessarily. Only re-do the tests for software requirements which were touched by the (code) change. But be sure to document your reasoning. L

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Anonymous

updated about 1 year ago

We’re currently using SaaS tools like GitHub to host our code. Our consultant told us that that’s not okay and we need to self-host everything. His reason was that we’re only allowed to use tools whic

Accepted answer

Your consultant is wrong. You can use GitHub. And look for another consultant. Long Answer The ISO 13485 requires you to “validate” all quality-relev

Should You Automate Your Software Architecture Documentation?

Anonymous

updated about 1 year ago

For our software architecture documentation, we’re planning to have some high-level system diagrams. Drawing these manually seems inefficient, and we fear that they’ll be outdated soon when we continu

Accepted answer

No. Do it manually. Long Answer Your software architecture diagram should be on a rather high level (see the example here). It’ll be really hard to a

Do Auditors Read Your Code?

Anonymous

updated about 1 year ago

We’re wondering whether our auditor will read the source code of our software. Does that mean we have to choose a programming language which many people know, like Python?

Accepted answer

No, your auditor won’t read your code. Long Answer Think about it this way: The probability of your auditor being a software developer is low (yes, I

How to document SOUP for IEC 62304 compliance?

Anonymous

updated about 1 year ago

Our python backend contains lots of dependencies, for example flask and the requests library. According to the IEC 62304, third-party dependencies are “SOUP” and must be documented. We have no idea ho

Accepted answer

You need to create a list of your dependencies. That list can be a spreadsheet, a markdown file, or pretty much anything else which you can save as do

Can We Document Our Software After We've Developed It?

Anonymous

updated about 1 year ago

We want to certify our software as a medical device, but we've already developed parts of it (or all of it). Do we have to re-do our entire development, creating "compliant" documentation along the wa

Accepted answer

Don't worry, young Padawan. You can document your software after you've developed it. This works for your first software version, i.e. the first medi

Videos

No videos yet.

Templates

No templates yet.

Tag: IEC 62304

Articles

Doing a Software Release in Compliance With IEC 62304

Software Verification For Medical Device Software (IEC 62304)

Writing Software Requirements Based on the IEC 62304

Software System Testing Based on the IEC 62304

IEC 62304 Walkthrough

Medical Device Software Architecture Documentation (IEC 62304)

Writing a Software Development and Maintenance Plan for IEC 62304 Compliance

Questions

Do We Have to Re-Do All Software System Tests After a Minor Change?

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Should You Automate Your Software Architecture Documentation?

Do Auditors Read Your Code?

How to document SOUP for IEC 62304 compliance?

Can We Document Our Software After We've Developed It?

Videos

Templates