Aproio works across the
development process
to help minimize risk
& increase reliability
of your products.
Following is a description of the Gateway Review Phases in our informed design process, which provides a brief list of some of what we deliver in each phase.
Phase 0
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Informs design
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Identify usability and human factors risk via summative studies
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Develop proof-of-concept & provide working demos
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Report results
Phase 1
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Conduct product planning, hazard analysis and risk analysis
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Spec requirements
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Review with stake-holders
-
Produce plans, documents & report results
Phase 2
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Produce Design history file (DHF)
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As needed, help in the selection of contract manufacturer(s)
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Update documents & report results
Phase 3
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Verify risk controls
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Following verification protocols, test product and report results
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Produce a trace matrix
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Update design history file (DHF) and output device master record (DMR) and device history record
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Produce a technical file
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Conduct formative studies
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Produce documents & report results
Phase 4
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User evaluation
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Field trials/animal testing/clinical trials and review of results
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Regulatory submission
Phase 5
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Transfer design files to manufacturer
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Feed RM results into manufacturing
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Conduct process Failure Mode Effects Analysis (pFMEA)
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Initiate supply chain
-
Update device master record (DMR)
-
Report results
Overview: Informed Design Process
