IEC 62304 compliance without the chaos

IEC 62304 doesn’t prescribe your documentation formats but it does expect you to connect the dots

In the world of medical device software, compliance often feels like a maze of documents, checklists, and reviews. But when it comes to IEC 62304, one of the most important standards for software as a medical device development, there’s a truth that often gets missed: IEC 62304 is a documentation standard that however doesn’t dictate how your documentation should look.

What it really requires is clear evidence that your software development process has been followed correctly and documented according to your software safety class, and that traceability exists throughout the entire software lifecycle.

It’s about process, not paperwork

Many teams assume that compliance means rigid templates or predefined document formats. In reality, IEC 62304 is flexible. It doesn’t prescribe the format of your documentation. It expects that every step, decision, and verification is traceable and supported by evidence.

The focus is on demonstrating that, at minimum:

• every software requirement links to a defined task or deliverable

• risk management and verification activities are documented and traceable

• reviews and key decisions are recorded, even when part of another document

This flexibility allows development teams to design documentation systems that fit their workflow while still maintaining full compliance with the standard.

Understanding what applies to your software class

IEC 62304 defines three software safety classes (A, B, and C) based on the level of risk associated with a potential software failure that might cause harm. The higher the class, the more stringent the software lifecycle documentation requirements.

The infographic below summarizes, clause by clause, which software development requirements apply to each class. This visual guide helps teams identify what’s relevant for their project scope and avoid unnecessary documentation.

You can use it to:

• plan your development and documentation activities

• tailor templates to include only the necessary clauses

• justify your approach clearly during audits and regulatory submissions

Aligning your process early with the right clauses saves time, reduces rework, and improves audit readiness.

The real challenge: scattered data

For most teams, the real problem isn’t understanding the standard, it’s managing the information.

Typically, it looks like this:

• requirements tracked in one excel sheet or a generic software ticketing tool

• risks managed in another excel sheet

• verification results stored in sharepoint

• reviews saved in a separate tool

On paper, everything may appear compliant. But in practice, maintaining traceability across disconnected systems becomes almost impossible. As projects scale or teams grow, version control issues and gaps in traceability can quickly appear.

Without a single source of truth, compliance becomes harder to prove, and harder to sustain.

How Matrix Req helps

Matrix Req was designed specifically to solve this challenge. It provides a unified platform that connects all aspects of the software lifecycle from software requirements, architecture description, detailed design and risks to testing, verification, and release.

With Matrix Req, you can:

• manage all lifecycle data in one place

• maintain automatic traceability between requirements, software items, risks, and tests

• simplify compliance with IEC 62304 and ISO 13485

• eliminate the need for scattered spreadsheets and manual tracking

This connected approach not only saves time but also builds confidence during audits and regulatory reviews. Everything is traceable, reviewable, and always up to date.

Building clarity and confidence in compliance

IEC 62304 is not about creating extra paperwork. It’s about ensuring clarity, safety, and accountability in medical device software.

When your processes are connected and traceable, compliance becomes a natural outcome of good engineering practice. Matrix Req helps medical device teams reach that clarity. It ensures that every relevant item of design is linked and visible, so compliance isn’t just achieved, it’s sustained.

Because in the end, compliance shouldn’t slow you down. It should help you move faster, with confidence.