IEC 62304 Lifecycle

IEC 62304:2006+AMD1:2015 defines the software development lifecycle processes required for medical device software. It is recognized by FDA, the European MDR/IVDR framework, and regulatory authorities worldwide as the principal standard for medical device software development.

Compliance with IEC 62304 is required (or strongly expected) for virtually all software-containing medical devices seeking 510(k) clearance, De Novo authorization, PMA approval, or CE marking under MDR Annex I.

Software Quality Guru helps manufacturers implement IEC 62304 pragmatically — building processes that are both compliant and efficient, without imposing unnecessary overhead on agile development teams.

A structured gap assessment is the essential first step for any team implementing or improving IEC 62304 compliance. We evaluate your current software development practices against each clause of the standard and produce a prioritized remediation roadmap.

Gap assessments cover: software development planning (Clause 5.1), requirements analysis (5.2), software architectural design (5.3), detailed design (5.4), implementation (5.5), integration and integration testing (5.6), system testing (5.7), software release (5.8), and the software maintenance (Clause 6) and risk management (Clause 7) clauses.

Findings are mapped to a gap register with effort estimates, priority ratings, and owner assignments — giving your team a clear implementation roadmap.

Having the right procedures in place is the foundation of IEC 62304 compliance. We author or remediate QMS procedures covering the full IEC 62304 scope, tailored to your team's tools and workflow.

Typical procedures we develop include: Software Development Plan (SDP) template, Software Requirements Management procedure, Software Configuration Management (SCM) procedure, Software Problem Resolution procedure, and Software Maintenance procedure.

All procedures are written to integrate with your existing QMS (ISO 13485 or QMSR) and tool stack — whether you use Jira, Azure DevOps, GitHub, Polarion, or a combination.

The Software Development File (SDF) is the collection of records demonstrating IEC 62304 compliance for a specific software version. It must be maintained throughout the product lifecycle and made available during regulatory inspections.

We help clients structure and populate SDFs including: software development plan, requirements specifications, architectural and detailed design documentation, unit/integration/system test records, software release documentation, and problem report logs.

For teams preparing 510(k) submissions, we produce the Software Documentation Checklist (per FDA's 2023 Software in a Medical Device guidance) and ensure all required documentation is included and cross-referenced.