Medical Devices: Requirements ALM Platform | Medical Equipment Manufacturing

Accelerate Innovation & Compliance in Medical Device Development

Simplify your complex product development, and begin ensuring end-to-end traceability and compliance across industry standards with Visure.

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Ensure End-to-End Traceability, from Source Code to Requirements & Testings

With Visure's modern Requirements ALM Platform you can guarantee to establish a full traceability across the entire product cycle, including from requirements, risks, tests and up to source code functions.

Additionally, you can trace compliance across all levels and access version control to measure chance and impact within the historical versions of your project.

Lastly, manage source code traceability between requirements and tests to specific functions of your source code, allowing you to easily generate reports for standard compliance audits.

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.

Such standards and regulations include:

• ISO standards for quality and risk management for medical devices (e.g., ISO 13485, ISO 14971)
• IEC standards for medical device lifecycle requirements (e.g., IEC 62304)
• FDA regulations applicable to medical device development (e.g., 21 CFR 820.30 and CFR Part 11)
• EU medical device directives and regulations
• Agile practices in medical device software development, AAMI TIR45

Increase Productivity, Alignment and Product Quality with Complex Project Management Features

What really differentiates a complete modern requirements management tool from a lightweight one?

The difference relies on the complex project management features that enable you to increase complex project speed to market and your team's productivity without sacrificing product quality nor standard compliance.

With Visure, you can use simplify and accelerate your compliance by using our tool qualification package, which will allow your team to validate the tool for compliance.

As a result, you'll increase both productivity and alignment within your team by ensuring a full end to end traceability, reusing requirements across projects, and automatically measuring requirements quality with AI.

Centralize Risk, Requirements and Test in a Single Platform

Visure connects risk, testing, and requirements in a single platform. Transform how you capture, analyze, evaluate and mitigate risks at each stage of the development process.

You can easily import and list risk factors into the platform, and implement the FMEA process and begin calculating risk. Once the high risk factors have been identified, you can easily create Safety Requirements related to them.

With Visure, you can customize item types at any level to fit your risk management process and begin to proactively avoid missed risks.

As a result, Visure's integrated risk, requirements and testing management software can help you save time and money while ensuring a higher quality product.

Integrate with Top Industry Solutions, Migrate from Legacy Tools, and Import & Export from and to MS Office easily.

Most global medical device companies come from legacy old tools, such as IBM Doors, that are slowing them down, while also unable them to digitalize their engineering teams. For this reason, at Visure we created easy import and export features from IBM DOORs as well as a simple migration feature to get started.

Additionally, with Visure you can access the best import and export feature from MS Office Word & Excel, and ease collaboration across supply chain by using international standard ReqIF for Data Exchange.

By gaining access to these features and top tier industry solutions integrations, you avoid manual rework through roundtrip requirements over multiple interactions, loss free, and without duplication.

Now you verify that all requirements are met, regardless of their original source, and in one single platform.

High-level Customization for Your Needs

Imagine having to adapt your development methodologies to every single tool your organization and team uses.

Or even worst, for medical device startups an agile and flexible tool is a must have tool in order to ensure speed to market and on-budget projects.

We've been through that as well, losing agility, productivity and speed to market because of high and unnecessary tool learning curves.

However, at Visure, we believe in tools having high-level customizations that can be flexible enough to adapt to your workflows and methodologies, not the other way around. Resulting in a lower learning adoption curve, and increase in both productivity and speed to market.

Why Top Leading Industry Organizations Choose Us

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

“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 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.”

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