Healthcare · Global · health-technology / medical-device leader · Quality Assurance
During an FDA inspection, the client (an over-century-old global leader in health technology) received findings flagging weaknesses in the risk-management strategy governing the correction and removal processes for its precision diagnostic-imaging products. The client had to strengthen product reliability, functionality, and safety for patients and operators while bringing its practices into full compliance with the ISO 14971:2019 and ISO/TR 24971:2020 medical-device risk-management standards across the product life cycle.
Amaris' specialized team ran a thorough retrospective examination of Health Hazard Evaluations (HHEs) and related reports, reviewing defect records, complaint data, design changes, CAPAs, SCARs, and other data, then implemented two reliable quality protocols and reevaluated 35+ product-related issues using qualitative and quantitative methods (hazardous situations, event sequences, at-risk populations, severity, occurrence rates) to align risk assessment with ISO 14971:2019 and ISO/TR 24971:2020 and optimize the QMS corrections-and-removals process.
5 people · senior specialists, regulated-industry · onshore · 6 months · time_and_materials
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Amaris Consulting · Part of Mantu. Figures shown are indicative and illustrative ranges based on the inputs you provide, not a quote. Comparisons refer to typical market ranges for equivalent seniority, not to any specific firm.