A curated list of tools, standards, and research projects to help medtech teams manage requirements and risk in compliance with IEC 62304, ISO 14971, and ISO 13485 (as well as FDA design controls).
Tip
This list is new, and is not exhaustive. Contributions are welcome!
| Symbol | Meaning |
|---|---|
| 🆓 | Open Source (or Free to Use) |
| 💰 | Commercial/Paid |
- Requirements Management Tools (standalone)
- Requirements Management Tools (in Jira)
- Requirements Management Tools (embedded in other tools)
- Requirements Management Tools (within eQMS)
- Interchange Standards
- Academic Projects & Research
- Templates
- Doorstop An open source requirements management tool that leverages Git for version control. 🆓
- OSRMT A free tool for full SDLC traceability of features, requirements, design, and tests. 🆓
- rmtoo Command-line requirements management via text files and version control. 🆓
- Eclipse RMF / ReqIF Studio An open implementation of the ReqIF standard for requirements exchange. 🆓
- Sphinx-Needs A documentation tool for managing and presenting requirements 🆓
- StrictDoc A documentation and requirements management tool with focus on traceability, custom fields, and source code linking. Supports export to HTML, RST, ReqIF, PDF, JSON, and Excel. 🆓
- ReqView A lightweight requirements management tool with Git integration, suitable for medical device compliance with full traceability and customizable templates. 💰
- IBM Engineering DOORS/DOORS Next Widely used in regulated environments, offering robust traceability and compliance support. Frankly better suited for large organizations. 💰
- Matrix ALM Designed for medtech, offering comprehensive traceability between requirements, risks, and tests. 💰
- Jama Connect A modern platform offering end-to-end traceability and review workflows. 💰
- Siemens Polarion ALM Features a dedicated MedPack template for IEC 62304 compliance. 💰
- PTC Codebeamer ALM Provides pre-configured medical process templates and dynamic traceability. 💰
- Visure Requirements An ALM solution with traceability across requirements, risks, and tests. 💰
- Cognition Cockpit/Compass A tailored platform for risk management with integrated hazard analysis and traceability. 💰
- Perforce Helix ALM Integrates requirements, test, and issue management for compliance. 💰
- Visure Requirements Generates comprehensive traceability reports aligned with IEC 62304. 💰
- Tento plus A requirements management tool with AI, suitable for medical device compliance with full traceability. 💰
Resources for setting up your Requirements and Risk Management in Jira:
- SoftComply Risk Manager (for Jira) A Jira plugin that transforms Jira into a risk tracker for ISO 14971. 💰
- Capable Risk for Jira A Jira plugin that adds support for risk management and traceability for ISO 14971, as well as CVSS for security risk assessment. 💰
- Snapshots for Jira A confluence/jira plugin for creating point-in-time snapshots of Jira data, such as requirements traces, as well as risk management. 💰
- Ketryx A Jira integrated tool which extends Jira with requirements management and risk management features, SBOM, security features, and more - everything needed to setup a medtech compliance workflow and agile delivery system. 💰
- Modern Requirements An Azure DevOps integrated tool for streamlined requirements management. 💰
Includes eQMS tools whcih have a requirements management function suitable for medtech. All feature ISO 62304/14971/13485 compliance.
- Greenlight Guru 💰
- Dot Compliance 💰
- Qualio 💰
- Open Regulatory Formwork 💰
- Matrix Requirements 💰
- Formly 💰
- ReqIF The OMG standard XML schema for exchanging requirements between tools. 🆓
- SpecIF An emerging vendor-neutral standard building on ReqIF concepts. 🆓
- OSLC Defines RESTful web service interfaces for real-time sharing of requirements data. 🆓
- OpenReq Project An EU H2020 initiative offering intelligent recommendations for requirements management.
- MDevSPICE Framework A consolidated process model integrating IEC 62304, ISO 14971, ISO 13485, and FDA controls.
- Multi-level Requirements Modelling Research Research on decomposing and tracing user needs through to software requirements.
- Standards Evolution and Trace Research Studies on adapting requirements management tools to evolving standards.
n.b. that most/all paid QMS tools provide templates.
- OpenRegulatory Templates Community-driven open templates covering IEC 62304, ISO 14971, and ISO 13485. 🆓
Contributions, improvements, and corrections are always welcome! Please use github issues and/or pull requests to contribute.