Pilot your ISO 14971 Risk Management,
your IEC 62366 Useability Engineering
and your Medical Device Design Process !
With Medical Device Suite, you can
- optimize your ISO 14971 Risk Management Analysis consistently from the Regulatory Affairs point of view
- optimize the functional analysis and FMEA studies done by the same device design and manufacturing process designers
- and ensure sustainable consistency.
According to your context and needs, you are free to use only one module or to capitalize sharing, data consistency and automations between the various modules.