Medical Device Suite : ISO 14971, Useability Engineering and Design Process
The software modules of Medical Device Suite facilitate the collaboration between Regulatory Affairs and Designers Services:
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Structure the methods of functional analysis, useability engineerng, FMEA and risk analysis
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Secure the audits (compliance, completeness, up-to-date, traceability,…)
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Ensure the consistency of the IEC 62366 useability report and of ISO 14971 risk managament report.
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Save a lot of time for the studies updates, the management of MD variants, printings…
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Manage the project complexity
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Involve and Motivate Teams.
