Meant for the Regulatory Affairs,
- RM 14971 software is dedicated to Risk Management on Medical Device, according to EN ISO 14971: 2012 and NF EN ISO 14971: 2013,
- and generate automatically the Risk Management Report (Chap. 8) .
An ISO 14971 Software Integrating Repositories
This software according to ISO 14971 risk management includes of repository items and french/English libraries.
It 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..
How to Manage Medical Device Risks ?
With RM 14971 you can make analysis, evaluation, risk control including those stemming from the measures, combined residual risks to lead to the acceptability of the overall residual risk
RM 14971 also enables to centralize in one unique database all risks and 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.
Rapport de gestion des risques : matrice de criticité, emploi prévu
Rapport de gestion des risques : classification des phénomènes dangereux et mesure de maîtrise du risque
Rapport de gestion des risques : risques résiduels combinés
Software suite for medical device Manufacturers
RM 14971 is a part of Medical Device Suite. So it enables you to share pertinent data, that do away with duplicate entries and any risk of inconsistency:
- Need: to integrate your customers’ viewpoints and structure the “real” needs with functional analysis
- Structure: to cross-reference needs and technical nomenclature or to optimize the (re)design of medical devices
- FMEA: for Design and/or Process FMEAs, control plans, manufacturing flow charts, workstation charts, and so on.