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:

  • Structure the methods of functional analysis, useability engineering, FMEA and risk analysis 

  • Secure the audits (compliance, completeness, up-to-date, traceability,…)

  • Ensure the consistency of the IEC 62366 useability report  and of ISO 14971 risk managament report.

  • Save a lot of time for the studies updates, the management of MD variants, printings

  • Manage the project complexity 

  • Involve and Motivate Teams.

Pilot your ISO 14971 Risk Management, your IEC 62366 Useability Engineering and your Medical Device Design Process !

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