Requirements Software for Medical Devices

Your Challenges

  • Software is exponentially growing in complexity and criticality.
  • Time to market takes companies to develop in parallel and implement branches which will afterwards be merged.
  • Deal with complex product lines to target different market segments is difficult and time consuming.
  • Perform your hazard analysis and risk assessment.
  • Keep track of approvals and reviews of the specifications.
  • Establish an effective validation and verification procedure and generate full traceability reports.
  • Automated creating of documentation used for Audits.

Our Benefits

  • Streamline the requirements process in order to achieve compliance with standards such as IEC 62304, FDA 21 CFR Part 820 and Part 11, ISO 14971 and regulations in a cost effective way.
  • Manage the traceability between your System and Software requirements, risks, risks control measures and mitigation, tests and any design artifacts. Generate full traceability reports.
  • In one click, generate reports and dashboards of the traceability, requirements coverage, test status, risk analysis and any artifacts needed for audits.
  • Save time and guarantee consistency by performing complete change impact analysis through end-to-end traceability and suspect links
  • Deal with the complexity of product lines and variants through component reuse.
  • Automatically flag low quality requirements with ambiguity or inconsistencies, through semantic analysis
  • Implement a test management process directly in Visure Requirements, or through the integration with third party products.
  • Keep control of the approval and review process through workflow capabilities and baseline signature.
  • Define and follow risk management and mitigation process, using techniques such as FMEA.
  • Identify and document problems and track their resolution.