Clinical Evaluation Template about rdm

[ahnurmi]

Hello! As per our discussion, clinical evaluation is required by the EU even if the device is of class I (least concern). It could go under the topic of product validation, as defined in IEC 82304-1 for software-only products and recognized by FDA.

I could write two templates called:

• Clinical Evaluation Plan
• Clinical Evaluation Report

as we have written such documents before.

Discussion topics:

1. Not everyone needs to perform clinical evaluation, i.e. when contract-developing a component instead of a product. Could there be some kind of option? Are there going to be too many options?
2. Reports are more project- than product-specific. One rarely needs to read old reports. Would it be helpful to have a project-specific subfolder for reports? (As opposed to main product documentation.)
3. Clinical evaluation could later be a part of a more general validation plan / report, where use requirements are traced to their validation.

Reference:

• MEDDEV 2.7/1 rev.4: Clinical evaluation: Guide for manufacturers and notified bodies

About product validation in general:

• IEC 82304-1:2016, section 6: Health software product validation
• ... or I guess there's something in IEC 60601-1 if the product includes hardware
• perhaps: General Principles of Software Validation; Final Guidance for Industry and FDA Staff

[johndgiese]

@ahnurmi thank you for writing out all of these details.

I am only familiar with 62304, but it would be great if we could support 82304-1 as well.

I have wondered about the best way to support options like this. It could be a prompt that occurs when you run rdm init. E.g.:

$ rdm init
Question 1 ... [Y/n]: Y
Question 2 ... [Y/n]: Y
Question 3 ... [Y/n]: Y
Documents generated in "your-project/regulatory".

Alternatively, we could keep the options in system.yml. But system.yml may get to be very large and confusing.

2. Agreed; it would be nice to put reports and/or records in subdirectories e.g. regulatory/release/clinical-evaluations/clinical-evaluation-001.md (for example; this name may not make sense)

3. We are still learning how software validation works in practice; our current templates are probably lacking in this area.