Tools to automate IEC 62304 and FDA standard requirements

Question

I am looking for a free software tool (or set of tools) to automate the document generation that requires the IEC 62304 and the FDA V&V standards (Software of Medical Equipments).

Basically, to maintain traceability between different documents, issue/bug trackers, SVN, source code, test cases, etc., report generation, document version control, project tracking, auditory functions, etc.

Earle

That's a huge software, I doubt free ones exist... have a look at mks.com/solutions/by-industry/medical-devices, polarion.com/products/medical/index.php or rallydev.com/industry/healthcare – Arnettaarnette

@scrooge Did you find something, or pieces of the pipeline, that worked out well? – Denticle

Answer 1

The Regulatory Documentation Manager (RDM) is a set of templates and python scripts which are designed to help automate IEC62304 compliance as much as possible. At its core, IEC62304 is all about using best practices to build high-quality software that has considered and mitigated as many risks as possible.

The stated design goals of RDM are:

1. Provide a generic template that covers common use-cases but is customizable.
2. Provide readable documents; e.g., other 62304 templates include many short deeply nested sub-sections. We use a maximum of two levels of nesting. We also provide flags (e.g., for different safety classes) that prune out irrelevant parts of the document, so that the documents only include what is necessary for the particular project.
3. Focused on software developers; the plan documents are intended to read and used frequently by the software developers on the team. Thus, wherever there was a tradeoff between making it easy to read for developers vs regulators/auditors, we optimized for developers. For example, we re-order IEC62304 sections to follow a more logical order for developers at the cost of being less parallel to IEC62304's structure.
4. Easy auditablility. In order to make it easier for regulators/auditors to read the document, we include auditor comments and links back to IEC62304. These links and notes are hidden by default, but there is a flag that enables turning them on. This way, we can use the "official" version without comments during our day-to-day work, but we can give the auditors two copies—both the "official" version and the "auditor" version that has all these extra notes.
5. Provide beautiful documents. A lot of times nobody readys requirements documents; we believe this is partly because the standard templates are large and ugly.
6. Make it as easy as possible to "upgrade" your documents when new versions of 62304 and related standards are developed.

The tool generates documents in markdown format, which are meant to be stored in source control, as well as in a PDF format. You can see examples of both the PDF and markdown versions here.

Please note that the tool is not complete, but it is under active development.

Sketchbook

Answer 2

Not really related to regulatory compliance, but maybe Axiom can help. It can generate Word documents from your requirements.

Arnettaarnette

Answer 3

There is a method called Model-Based Design by MathWorks which helps to integrate and automate most of the V&V processes required by the IEC 62304 for medical software development. In this way you can fulfil the steps all the way from requirements management to software integration and testing. The documentation artefacts required by the standard are automatically generated in the process.

Currant