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Technical Documentation 10 answers

How to ensure user manual readability and usability during testing?

Anonymous · Published March 14, 2026
What are effective methods for ensuring that user manuals or Instructions for Use (IFUs) are readable and usable during testing? Are there recommended tools or formulas for assessing readability?

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10 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
We discussed this topic with our auditor, who recommended marking Section 7.6 as not applicable for SaMD. However, auditors can have different opinions, so it's best to prepare your reasoning and see if it holds up during your audit. Sometimes, server monitoring applications or automated testing tools are considered, but often this clause is more relevant to physical devices.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Matrix Requirements and OpenRegulatory are both good starting points for SaMD companies. Matrix is quite popular and offers a demo if you need an intro. Other companies use Scilife as well. It's always wise to talk to your team, especially developers, to get their input before deciding. For some, a highly configurable or even a semi-custom solution (like markdown in git linked to issue trackers) works best.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
It's not strictly necessary to use a dedicated server. What's most important is how you manage security, data flow, and access. Doing a thorough threat modeling analysis will help you identify any vulnerabilities, regardless of whether you're using a dedicated or virtual server. Sometimes, putting a VM behind an API or disconnecting it from the internet can be enough to address compliance and security concerns.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
You should only consider hazards that are caused by software failure when assigning the software safety class under IEC 62304. Hazards caused solely by use error fall under the scope of IEC 62366-1, which deals with usability engineering.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
This is pretty common. You can document your approach in your technical file, stating that "1.0" and "1.0.0" are interchangeable for your product. Alternatively, you can use versioning like "1.0.x" to cover all minor/patch updates. Just make sure to keep it consistent and explain the logic somewhere in your documentation.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
There are stories about continuous learning AI/ML systems being certified in the EU, but nothing public or official. Some Notified Bodies might be open to it, but it depends on the specific NB and the device. There's no general ZLG guidance banning this—earlier reports were misinformation. If you can demonstrate that updates are always beneficial or not unacceptably worse (based on risk), you might frame it as calibration, but getting approval is still very complex.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
I haven't seen a publicly available checklist for ISO 27001:2022, but you might want to check with colleagues or industry contacts—sometimes people have worked on these and are willing to share. As for commercial options, references for where to buy them would also be helpful. The EU is also moving towards making harmonized standards more accessible, so keep an eye out for updates.

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
User testing is a great way to see if people read and understand your IFUs or user manuals. You can also use readability formulas in Word or other tools, but these are not always reliable. The key is to observe how users perform tasks—whether they need to reread the manual, make mistakes, or find everything intuitive. Real-world testing often reveals more than automated tools.

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A
Anonymous ·
Having ISO 27001:2013 or SOC 2 certification is definitely helpful for SaMD data storage, but depending on your jurisdiction and the type of medical data, there may be additional regulatory requirements. Always check what local regulations require in addition to these certifications.

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Anonymous ·
I don't have a Clinical Investigation Plan template myself, but you might want to check with colleagues or see if anyone in your network is willing to share one. Sometimes industry associations or regulatory consulting firms provide templates as well.

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How do you validate and test your medical device IFU (Instructions For Use)?

Anonymous · 1 comment
12 months ago
Our team has previously added one or two tests about the IFU to our usability tests, but this approach felt awkward for testers and did not cover the entire IFU. We are seeking practical methods to va
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about 2 years ago
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Our recommended strategy for MDR class I and IIa would be this: • Have an electronic user manual which is accessible in your app by e.g. linking to

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