#1 IEC 62304 SOFTWARE & ALM TOOL

Ensure IEC 62304 Compliance.
Enforce Traceability.
Ease & Accelerate Your Audits.

Unlock efficiency and empower engineering teams with the leading IEC 62304 & ALM software tailored to Medical Device companies and designed to enforce traceability, and improve speed and quality while lowering risk and cost.

1,000+ Highly Regulated Organizations Trust Visure

What is IEC 62304, and Why is it important?

Functional safety is an important consideration in the design and maintenance of medical device software. IEC 62304 is a functional safety standard that covers the safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.

The standard covers a wide range of aspects related to functional safety, including hazard analysis and risk management, software development and testing, configuration management, and change control. By following the processes and tasks outlined in IEC 62304, developers can help ensure the safe design and operation of their software.

Guarantee Medical Device Standards and Regulations Compliance with Industry Templates

Visure Requirements ALM centralizes requirements, tests, defects and risks in a single platform, gaining control and a full end-to-end traceability. This helps organizations in enforcing their process to comply with IEC 62304 and creating the necessary deliverables to meet the software safety classes.

Achieve IEC-62304 Compliance with an All-in-One AI-powered Medical Device ALM Software

Accelerate Requirements Gathering & Elicitation

Get faster requirements elicitations by authoring, reading, and editing items in a single view without losing visual context in the overall document.
Achieve a balance between atomic requirements management and traceability, all while maintaining a familiar document-style approach.

Enforce Product Traceability

Gain end-to-end traceability for Risk, Requirements, and Tests. Implement a robust change management process to uncover process interdependencies and maintain project success.

Effortlessly explore upstream and downstream relationships, anticipate change impact, monitor cross-project relationships, detect potential link issues during changes, and visualize relationship rules across projects to understand their organizational impact and reach.

Ensure Compliance & Manage Risk

Reduce risk and simplify compliance audits. Visure facilitates early and ongoing risk analysis, allowing you to identify, estimate, and assess risks.

Keep your risk analysis current with real-time data, improve coverage by tracing open risks to requirements, build a comprehensive risk management profile using PHA and FMEA techniques, and guarantee quality and safety in intricate product development.

Reuse Requirements & Baseline Management

Speed up development and maintain consistency. Easily compare requirement versions, organize and secure your data, and create development stream baselines or requirement catalogs.

Compare changes in requirements, ensure data organization and security, snapshot project states, build reusable requirements catalogs, and develop product variants or new versions.

Manage Test & Quality Processes Systematically

Effortlessly manage real-time testing. Create, organize, and execute plans, cases, and reports. Log defects instantly, prioritize and discuss in real-time. Connect tests, integrate tools, and produce tailored compliance reports for auditors.

Analyze Requirements Quality

Automatically analyze the quality of requirements while writing them. Avoid ambiguous specifications from poorly written, ambiguous, and inconsistent requirements.

Enhance Team Collaboration

Ensure secure, cross-functional collaboration across teams, customers, and complex supply chains to remove friction throughout the development process

Enable Advanced Reporting

Visure tutorial export Generate customized documents and reports from your database, helping deliver the necessary regulatory compliance evidence, specifications, test session summaries, or any other required output.

Import & Export Seamlessly

Increase your productivity and ease your Stakeholder review process by using simple import and export data features for ReqIF, and MS Office Word & Excel.

Automate Your Proof of Evidence.
Optimize Your DO-178C & DO-254 Certification Compliance.

With Visure, you can use automated checklists to manage compliance and easily integrate and access our DER partner’s checklists into our tool. This will enable you to design and improve a review process around these checklists.

Why Top Leading Medical Device Companies Choose Visure For IEC 62304 Certification

Reduce Risk & Manage Standard Compliance

Mitigate Risk and avoid stressful compliance audits across projects by centralizing and tracing in a single source of platform.

Full end-to-end Traceability, including Source Code

Configure your data model and gain full traceability between tests, requirements, risk, defects and all items, including source code to specific requirements.

Simple Import and Export Data

Increase your productivity by using simple import and export data features from ReqIF and MS Office Word and Excel.

Facilitate Real Time Collaboration & Alignment

Visure integrates bi-directionally and automatically with the top industry engineering tools, easing collaboration among teams in real time.

Easy to use UX/UI Requirements ALM Tool

Forget about legacy tools user friendly experience, and implement an easy to use Requirements ALM tool with a low learning curve.

Most Value to Price Product in the Market Guaranteed

We are committed to your team's project success by delivering within budget. That's why Visure's pricing is a fraction from other competitors.

Maintain Security Across Development

With our On-Premise Licensing option, you can easily deploy and maintain security across all your projects within the tool.

Accelerate Project Speed to Market

Increase your team's productivity with reusability of components across projects and automating repetitive tasks through open source code & AI.

Access Premium Support, Trainings and Consultations

Fast track your team's success by getting your team up and running easily, while staying on top with industry best practices.

Visure Requirements ALM Connects with Best-of-Breed AVIATION SOFTWARE

And even more integrations with other leading software — including automated test solutions— to accelerate and facilitate success across the entire product development lifecycle.

What industry professionals say about us

“Visure tools helped identify deficiencies in our traceability from using traditional spreadsheets for a mission critical customer.”

“The quicker the developer can demonstrate the proof of the completed reviews, the more credibility they show to the certification authorities such as FAA and EASA.”

“Visure Requirements ALM removes the administrative overhead of keeping multiple Word/Excel documents up to date, while maintaining a flexible approach which fits with our existing ISO processes.”

“Visure Requirements ALM Platform really simplified the project traceability and impact analysis process, that used to be very time consuming before Visure”

As posted in G2, SoftwareReviews and TrustRadius.