Automate Your Proof of Compliance Process & Audits for IEC 62304
Empower engineering teams building complex products or systems, while reducing project costs by simplifying your standard compliance process in a single platform.
What is IEC 62304, and Why it's 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 safe design and maintenance of software. It provides processes, activities, and tasks to ensure safety.
These applies to the development and maintenance of medical device software when: The software is itself a medical device; when it is used as an accessory to a medical device; when it adjusts or modifies the functionality of a medical device; or when it interacts with a patient.
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.
Ensure End-to-End Traceability for Compliance
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.
This means, that within Visure, teams can create, enforce and manage many-to-many bidirectional traceability links at all level of requirements decomposition, risks identification and mitigation, testing plans and results, problem report and changes, software items, etc.
This includes the traceability between the system requirements, software requirements, software system tests, risk control measures, hazards and changes.
Traceability matrices and reports can be automatically generated, as well as traceability views across the project displaying upstream and downstream links.
Increase Productivity, Alignment and Product Quality with Dedicated Templates and Processes for IEC 62304
With Visure, engineering teams can access industry compliant IEC 62304 Templates and fully customize them to enforce compliance across the project and organization.
Additionally, artifact baselines can be signed by project stakeholders as defined by the process. This helps setting up a baseline approval process and follow the FDA guidelines on electronic signature.
Visure enables teams to generate customized reports, with dashboards and metrics that fully trace with the IEC 62304 certification process for compliance audits, and enables reusability of requirements components across multiple projects. This results in an increase of productivity and speed to market, while reducing cycle times and development costs.
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 producitivity 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.