Download an entire system of templates (Procedure + templates) covering the entirety of the IEC 62304/AMD1:2015 standard. All templates are available in Word format (.docx) and can be customised. The templates contain the experience gained from several regulatory submissions for different software classes. It supports development and quality teams in preparing clear, consistent, and compliant documentation for medical device software.
IEC 62304 defines the complete software lifecycle for medical devices from planning and requirements to release and maintenance.
Each phase requires documented evidence of development, verification, and control.
This bundle mirrors that structure exactly:
The templates are suitable for : Software engineers working on medical devices, Quality and regulatory specialists, Consultants supporting SaMD MDR/IVDR submissions
The bundle contains an ecosystem of 14 templates that cover all the requirements of the IEC 62304 standard; don't waste time starting from scratch, use our experience for your project.
Each template follows the IEC 62304 structure, helping teams organize their documentation efficiently. They are easy to adapt to different software safety classes and project sizes.
✓ Editable Word (.docx) and Excel (.xslx) files
✓ Ready for integration into your QMS
✓ Immediate access after purchase
You will find a complete process with an ecosystem of templates, with a clear identification of what is applicable to each class of software.
You will find clearly what is applicable to each class of software and which documents need to be completed.
Fill in the information for your device directly in our pre-filled templates, with our advice integrated directly into them.
The bundle contains 14 editable templates covering the full IEC 62304 software lifecycle from planning and design to verification, release, and maintenance :
15 pages (.docx)
Defines the complete software lifecycle framework for medical device software, covering planning, risk management, maintenance, and configuration control in line with IEC 62304 requirements.
20 pages (.docx)
Defines the organization, methods, and activities for software development under IEC 62304, including lifecycle phases, team responsibilities, milestones, tool management, and documentation control to ensure traceable, compliant project execution.
13 pages (.docx)
Defines how software versions, configuration items, and source code are controlled throughout the lifecycle, ensuring traceability, integrity, and secure release management in compliance with IEC 62304.
19 pages (.docx)
Defines all functional, performance, usability, and regulatory requirements for the medical device software, ensuring full traceability, testability, and compliance with IEC 62304 and ISO 14971.
21 pages (.docx)
Describes the complete system and software architecture, including hardware components, interfaces, data flows, SOUP integration, and design justifications to support traceability and IEC 62304 compliance.
11 pages (.docx)
Describes the detailed design of each software component, including architecture, data flow, algorithms, interfaces, and SOUP usage, ensuring full traceability to requirements and verification criteria.
Excel (.xlsx)
Provides complete bidirectional traceability between requirements, design, tests, and risk controls, ensuring every software element is verified and compliant with IEC 62304 documentation standards.
6 pages (.docx)
Provides a structured framework for conducting and recording design reviews, ensuring that design inputs, outputs and verification meet regulatory and safety requirements before release.
9 pages (.docx)
Defines the overall testing strategy, environment, and schedule for software verification ensuring full coverage of IEC 62304 requirements with clear traceability to system and risk controls.
9 pages (.docx)
Details all software test cases, including objectives, setup, inputs, expected results, and verification methods, ensuring traceable and reproducible verification software requirements.
5 pages (.docx)
Summarizes all executed test results, linking each to verified requirements, with clear status tracking, identified anomalies, and final conclusions on software compliance.
12 pages (.docx)
Describes the released software version, including configuration details, dependencies, known issues, improvements, and verification status, supporting design transfer and CE-marking documentation.
11 pages (.docx)
Defines the post-release maintenance process, covering feedback management, problem resolution, risk assessment, updates, and traceability to ensure ongoing software safety and regulatory compliance.
8 pages (.docx)
Captures, assesses, and tracks software issues from detection to closure, documenting root cause, risk impact, corrective actions, and verification results to maintain regulatory compliance.
You've got questions. We've got answers.
Yes. Each document includes sections that can be scaled to the software safety class defined under IEC 62304. You can simplify or expand based on your classification.
You’ll still need to populate them with your own product data, requirements, and test evidence. The structure, traceability, and compliance logic are already done, you save the weeks usually spent building them from scratch.
Editable Microsoft Word and Excel files, ready to integrate into your document control system. No locked sections or proprietary formats.
Yes. They follow recognized IEC 62304 structure and terminology. Several teams have used this set successfully during MDR/IVDR submissions and audits.
That’s fine. The templates don’t dictate a waterfall approach. They can document agile, hybrid, or iterative lifecycles as long as traceability, verification, and design control are maintained.
Very partial, the template mentionned the cybersecurity aspect but does not cover IEC 81001-5-1 compliance.
Auditors care about consistency and traceability, not originality. Using structured templates actually demonstrates control as long as the content is product-specific and accurate.
No. These templates reference risk control links but don’t redefine your process. They integrate naturally with an existing ISO 14971 risk file. Please note the full set of ISO 14971 docs is not integrated in this bundle.
Several templates (notably SOP-00 and SOFT-7) reference usability evaluation and link it to risk and design reviews. This avoids duplication across 62304 and 62366 documentation. Please note 62366 docs is not included here.
You can document supplier deliverables, verification, and integration activities directly within the lifecycle templates. This ensures compliance with MDR Article 10(9) and IEC 62304 §5.1.5 on external contributions.
Minimal changes. The structure supports IEC 62304, which the FDA also recognizes. You may just need to adjust some terminology.