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Delivering Advanced Engineering Solutions |
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As part of our services to our medical device manufacturer clients, AESC has performed series of analysis as per ISO 14791, which includes reliability, FMECA, and fault tree analysis.
Objective of these analyses have been, operation personnel, end user, and patient safety, as well as equipment reliability in general.
These analyses were conducted as part of an overall PQA program, to meet and satisfy FDA requirements.
We have also provided FMECA, and fault tree analysis services as components to clients' existing PQA program, or FDA certification process.
The following is an outline of risk management tasks specific to medical devices and detailed in ISO 14971:
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i.Intended use / intended purpose and identification of characteristics related to the safety of the medical device
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ii.Identification of known or foreseeable hazards
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iii.Estimation of the risk(s) for each hazard
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i.Risk acceptability decisions
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ii.Implementation of risk control measure(s)
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iii.Residual risk evaluation
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v.Other generated hazards
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vi.Completeness of risk evaluation
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2.Overall residual risk evaluation
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4.Post production information
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a.Post production experience
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b.Review of risk management experience
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