IEC 62304 Medical Device Software Full Compliance Kit
The complete IEC 62304 document library. 35 professionally written templates covering the full software lifecycle from initial planning through post-release maintenance.
Software Development Plan
Template document
Configuration Management Plan
Template document
Project Management Plan
Template document
+ 1 more templates
Complete document set
What's included
Everything you need to build a complete compliance documentation set.
- Software Development Plan
- Configuration Management Plan
- Project Management Plan
- Software Safety Classification Record
- Software Architecture Document
- Architecture Verification Record
- Configuration Management Records
- SOUP List and Documentation
- Software Requirements Specification
- Requirements Verification Record
- User Needs List
- Traceability Matrix
- Detailed Design Specification
- Detailed Design Verification Record
- Software Unit Verification Records
- Integration Test Plan and Records
- System Test Plan, Descriptions, Report
- Software Problem Resolution Process
- Problem Report Records
- Software Risk Management Records
- Software Release Documentation
- Known Residual Anomalies Record
- Release Verification Checklist
- Software Validation Plan and Report
- Software Maintenance Plan
- Feedback Monitoring and Evaluation Records
- Change Request and Implementation Records
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- SaMD teams building a complete, audit-ready software technical file from scratch
- Organizations needing full lifecycle traceability from user needs through post-release
- QA/RA leads needing the broadest possible IEC 62304 document coverage
- Companies preparing for NB review, FDA submission, or internal quality audits
- Organizations only needing mandatory documentation
- Teams with simple software that doesn't require full lifecycle documentation
- Those unfamiliar with IEC 62304 requirements
Why teams choose this pack
Practical benefits without the hype. Here is what you actually get.
Clarity from the start
No more staring at blank documents. Each template shows you what belongs where and why it matters.
Hours saved on structure
Skip the research phase. Start with proven layouts that align with regulatory expectations.
A path to follow
The included guides give you a practical sequence so you know what to tackle first.
Foundation to build on
These templates grow with you. Adapt them as your compliance program matures.
Questions about this product
Common questions specific to this template kit.
Ready to get started?
Skip the blank-page anxiety. Start with structure that aligns with IEC 62304 and adapt it to your context.
Instant download. Free updates. Single organization license.