IEC 62304 Medical Device Software Mandatory Documents Kit
IEC 62304 defines the software lifecycle requirements for medical device software. This kit contains the 23 core documents that auditors, notified bodies, and regulators expect to see.
Software Development Plan
Template document
Software Maintenance Plan
Template document
Software Safety Classification Record
Template document
What's included
Everything you need to build a complete compliance documentation set.
- Software Development Plan
- Software Maintenance Plan
- Software Safety Classification Record
- Software Configuration Management Plan
- SOUP (Software of Unknown Provenance) List
- Software Requirements Specification
- Requirements Traceability Matrix
- Change Request Log
- Software Architecture Document
- Software Unit Design Specification
- Software Unit Verification Checklist
- Software Integration Test Plan
- Software Integration Test Protocol
- Software System Test Plan
- Software System Test Report
- Known Anomalies List
- Software Risk Management Plan
- Software Risk Analysis
- Software Risk Control Measures Record
- Software Risk Evaluation Report
- Validation Plan and Report
- Software Release Checklist
Is this right for you?
We believe in being upfront. Here's who this pack works best for.
- Medical device software teams building regulatory submissions under EU MDR or FDA
- QA and regulatory affairs leads responsible for IEC 62304 compliance documentation
- Software developers at medical device companies needing structured lifecycle records
- Startups building Software as a Medical Device (SaMD)
- Organizations already certified with complete documentation
- Teams needing post-market or maintenance documentation
- Those unfamiliar with IEC 62304 software lifecycle 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.