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