#1 ALM SOFTWARE FOR MEDICAL DEVICES DEVELOPMENT
Enable Agile & Digital Engineering.
Enforce Traceability & Compliance.
Accelerate Your Timelines.
Simplify your complex product development, and begin ensuring end-to-end traceability and compliance across industry standards with Visure.
- Most cost-effective
- Access All Features
- 14-day Trial
1,000+ Highly Regulated Organizations Trust Visure














Guarantee Medical Device Development Standards and Regulations Compliance with Industry Templates
Transform medical device development work across all design control, hardware and software engineering teams with a modern platform that is designed for medical device development safety-critical standards and regulations, resulting in speed time to market without sacrificing compliance, nor product quality.
- ISO 13485
- ISO 14971
- IEC 62304
- FDA 21 CFR 820.30
- FDA 21 CFR Part 11
- AAMI TIR45
- EU Regulations
- FMEA, FMECA, DFMEA
Achieve Project Success with an All-in-One AI-powered Medical Device ALM Software
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.
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.
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.

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.
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.

Automatically analyze the quality of requirements while writing them. Avoid ambiguous specifications from poorly written, ambiguous, and inconsistent requirements.
Ensure secure, cross-functional collaboration across teams, customers, and complex supply chains to remove friction throughout the development process
Generate customized documents and reports from your database, helping deliver the necessary regulatory compliance evidence, specifications, test session summaries, or any other required output.
Increase your productivity and ease your Stakeholder review process by using simple import and export data features for ReqIF, and MS Office Word & Excel.
Why Top Leading Medical Device Companies Choose Us
Visure Requirements ALM Connects with Best-of-Breed Tools
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
As posted in G2, SoftwareReviews and TrustRadius.
Ensure Medical Device Compliance.
Enforce Full Traceability.
Accelerate Your Timelines.
- Most cost-effective
- Access All Features
- 14-day Trial
On average, our customers experience:
See what’s possible with a Modern Medical Device ALM Software Solution
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