Risk Assessments

EirMed’s strict adherence to risk assessment guidelines ensures compliance to ISO 14971 and FDA protocols. Our risk management system mitigates risk in the development, production and post-production of medical devices, as well as material and equipment procurement.

At the beginning of the manufacturing process, we conduct a Process Failure Mode Analysis (PFMA) to identify potential hazards and prevent them from materializing. During inspection risk associated with manual inspections have been mitigated by implementation of automated inspection equipment.

Risk mitigation also includes the diversification of suppliers – we source materials and equipment from multiple vendors in order to ensure smooth procurement, high quality and rational costs.

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