IEC 62304 - Medical Device Software - The ultimate cheat sheet of software design requirements

IEC 62304 doesn’t prescribe your doc formats. But it does expect you to connect the dots.The standard does not impose a predefined documentation structure. What it requires is clear evidence of process execution and traceability across the lifecycle activities.

This includes:

• Linking each requirement to a task or deliverable

• Ensuring risk management and verification activities are documented

• Recording reviews and decisions, even if they exist as part of another document

The infographic below summarizes clause-by-clause which software development requirements apply depending on the software safety class (A, B, or C). It can be used to:

• Plan your development and documentation activities

• Adjust templates to match only the necessary clauses

• Provide clear justification during audits and regulatory submissions

But here’s the challenge:

• Requirements in Excel spreadsheet

• Risks in other Excel spreadsheet

• Verification in SharePoint

• Reviews in yet another tool

All “compliant” on paper; but nearly impossible to maintain, trace, or scale.

Download our guide now for more details!