Medical Device Suite is a range of modules. “ISO 14971 Risk” is the software dedicated to Risk management according to ISO 14971:2013. logiciel-rm-iso-14971

Analysis, evaluation, risk control including those stemming from the measures, combined residual risks to lead to the acceptability of the overall residual risk.

Meant for the Regulatory Affairs, this ISO 14971 software offers to make the risk analysis through all stages of the life-cycle of a medical device : design, manufacturing, transport, storage, functioning, maintenance, disposal …

It integrates libraries for events, initiators, hazards, harmful effects on human, equipment damages and environment damages as per the CETIM guide.

These references can be enriched/modified by the user. Your specific references are completed and capitalized over time: hazardous situations, to do actions…

Our software for ISO 14971 Risk Management also enables to centralize in one unique database the follow-up of action plans. The software module can be fully tailored to your history and knowledge, all elements (interfaces and trade-specific references) are bilingual French/English. Lastly, the Risk management report (chap.8) generation can be fully automated.

See also how to optimize your design process 

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