Overview: Informed Design Process

Aproio works across the development process to help minimize risk & increase reliability of your products.

 reliability | realized

Learn more about our development phases

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

  • Informs design
  • Identify usability and human factors risk via summative studies
  • Develop proof-of-concept & provide working demos
  • Report results
  • Phase 1

  • Conduct product planning, hazard analysis and risk analysis
  • Spec requirements
  • Review with stake-holders
  • Produce plans, documents & report results
  • Phase 2

  • Analyze, design, build, test product
  • Produce Design history file (DHF)
  • As needed, help in the selection of contract manufacturer(s)
  • Update documents & report results
  • Phase 3

  • Verify risk controls
  • Following verification protocols, test product and report results
  • Produce a trace matrix
  • Finalize DHF, DMR and DHR
  • Produce a technical file
  • Provide Regulatory input, compliant with 510(k) 
  • Conduct formative studies
  • Produce documents & report results
  • Phase 4

  • User evaluation
  • Field trials/animal testing/clinical trials and review of results
  • Regulatory submission
  • Phase 5

  • Transfer design files to manufacturer
  • Feed RM results into manufacturing
  • Conduct process Failure Mode Effects Analysis (pFMEA)
  • Initiate supply chain
  • Update device master record (DMR)
  • Report results
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