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Microsoft Partner

Go-to Microsoft partner for requirements management since 2015

Azure DevOps

Tools designed for Healthcare and Medical Devices Companies

Modern Requirements4DevOps is a requirements management solution built into Azure DevOps to meet the compliance, testing, and validation needs of the healthcare, life sciences, biotechnology and medical device industries.

Requirements Management Tools for the Healthcare and Medical Devices Industry

Trusted by the World’s Leading Healthcare Companies:

We’ve got the Solutions to your Challenges

We understand how tough it can be in a heavily regulated industry that is governed by reliability, safety, security and quality-control factors. With ever-evolving regulatory compliance; organizations like yours can be reassured that you can rely on trusted and proven technologies like Modern Requirements4DevOps. Get powerful requirements management tools to help manage complex regulatory needs, advanced reporting and testing and validation solutions.

Modern Requirements4DevOps

Online Reviews

Online Part 11 Compliant Reviews that bring teams together. Collaborate with your entire team in the same space with our free-to-participate reviews!

One-Click Reports

Maintain auditability through the use of our one-click reporting tools. Create difference reports show the changes between two sets of work items, or review audit reports complete with timestamps.


Our tool includes an electronic signature feature that is integrated with our workflows to ensure compliance with all necessary regulations.

Requirements Documents

Build requirements and documentation at the same time using our industry-recognized Smart Docs tool. Allow your team to build documentation directly within your Azure DevOps/ TFS projects.

Trace Analysis

Report on your test coverage by creating Traceability Matrices that can be easily turned converted into Excel Documents. Identify orphaned requirements and build coverage quickly and easily.

Baselining, Validation and Testing Report

MR4Devops has been validated by hundreds of companies and we’re happy to share the results with you

The only Requirements Management tools built into Azure DevOps for Healthcare and Medical Device companies

Define and Mitigate Risk and Hazards

Our Requirements Management solutions offer teams the ability to easily create Risk and Hazard work items that define and link Risks and Hazards to other requirements within your project. We even offer fully compliant requirements templates that allow you to get started with your Azure DevOps project quickly and with everything you need to mitigate Risks and Hazards.

Manage Reviews and Approvals of Requirements

Use our CFR 21 Part 11 Compliant online reviews to streamline your approval process. Remove approval delays by actively involving your Stakeholders in the approval of both Azure DevOps Work Items as well as Requirements Documents you create in our Smart Docs module (built seamlessly into Azure DevOps). To increase auditability, we allow you to easily request e-signatures, or create one-click reports that detail, and timestamp, all actions, comments, and changes that occurred during a review process!

Control Release Scope with Baselines

Use Reviews and Baselines in tandem to easily facilitate, identify, and manage the changes to requirements. Our workflow tools provide your team with the ability to easily manage scope creep and identify places where changing requirements need to be reassessed. We promote Regulatory Compliance by helping you build reusable repositories of Compliance Requirements.

Baselines in Azure DevOps
Requirements Test Coverage in Azure DevOps

Ensure Requirements and Test Coverage

Use fully configurable, and always up-to-date, traceability matrices that allow you to easily ensure traceability project wide. Support Regulatory Compliance by exporting your Requirements Traceability Matrices to Excel for easy storage. Our matrices can be created in minutes and are always up-to-date. This allows team to easily view project traceability quickly, with the ability to turn any matrix into a distributable report with the click of a button.

Schedule a demo to see how we can simplify compliance for your organization

Learn how Documentation, Reviews, and Baselines can help you maintain regulatory compliance!

Two Easy Ways to Try
Modern Requirements4DevOps

Both options include access to support and training resources for requirements management best practices!

Try in My Own Environment

Your data, your projects, our extension

By trying from the comfort of your existing environment you can see how our requirements management tools interact with your existing data.

Try in Modern Requirements

Use our requirements management tools in our sample environment

Try our pre-built Compliance, BABOK, Product Development, or Agile/SCRUM templates without worrying about configuration or installation.

Learn More

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