Automate Your Proof of Compliance Process & Audits for ISO-14971
Empower engineering teams building complex products or systems, while reducing project costs by simplifying your standard compliance process in a single platform.
Visure transforms the way these companies comply to industry standards and develop complex products.
What is ISO 14971?How is it important?
ISO 14971, titled "ISO 14971 Medical Devices - Application of Risk Management to Medical Devices", holds significant importance within the medical device industry. This standard is akin to ISO 50126 in the railway sector, emphasizing risk management as a pivotal component in ensuring the safety and effectiveness of medical devices.
ISO 14971 is crucial as it provides a systematic approach to identifying, assessing, and mitigating risks associated with medical devices throughout their entire lifecycle. It places rigorous requirements on manufacturers to analyze potential hazards, evaluate the probability and severity of harm, and implement appropriate risk control measures. Compliance with ISO 14971 is essential to enhance the safety and reliability of medical devices, protect patients and users, and meet regulatory requirements.
Unify Risks, Requirements, and Testings With A Single Platform
Visure seamlessly integrates risk, testing, and requirements management into a unified platform. Revolutionize how you capture, assess, analyze, and mitigate risks at each stage of your development process.
Importing and cataloging risk factors within the platform is effortless, enabling the swift implementation of the Failure Modes and Effects Analysis (FMEA) process while quantifying risks. Once high-risk factors are identified, generating Safety Requirements that correspond to them becomes a streamlined process.
Visure empowers you to tailor item types to match your specific risk management approach, enabling proactive risk prevention and mitigation.
Ultimately, Visure's integrated risk, requirements, and testing management software saves time and resources and ensures the delivery of a higher-quality product, aligning seamlessly with ISO 14971 compliance requirements and best practices.
Establish Comprehensive End-to-End Traceability For ISO 14971 Compliance
Visure Requirements ALM is a central hub that consolidates requirements, tests, defects, and risks within a unified platform, offering meticulous control and seamless end-to-end traceability. This robust functionality empowers organizations to enforce their processes, ensuring compliance with ISO 14971, and enables the creation of essential deliverables aligning with software safety classes.
Within Visure, teams can effortlessly create, enforce, and manage many-to-many bidirectional traceability links across various levels of requirements decomposition, risk identification and mitigation, testing plans, and results, problem reports and changes, software items, and more. This extends to the intricate traceability between system requirements, software requirements, software system tests, risk control measures, hazards, and changes.
Visure automates the generation of traceability matrices and reports, alongside providing comprehensive traceability views throughout the project, showcasing both upstream and downstream links. This holistic approach to traceability ensures that organizations can effectively navigate ISO 14971 compliance requirements while enhancing transparency and control across the entire development lifecycle.
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.
