Design Process

We employ industry standards for phased development. Our phase development approach requires gate reviews. Gate reviews ensure that the requirements of each phase have been met prior to advancing to additional phases.

Phase 0

  • Survey the market to define marketing requirements
  • Understand user needs, perform user hazard analysis and perform formative study
  • Analyze and appraise technology
  • Develop conceptual design and simple proof-of-concept (PoC) feasibility units
  • Document the results

    • Phase 1

  • Initiate planning documents such as Project Plan and Deliverables List
  • Perform Hazard and Risk Analysis feeding the output to product requirements
  • Create product requirements and product architecture
  • Review work products from this phase
  • Create initial Design History File (DHF)

    • Phase 2

  • Develop plans such as Software Development Plan and Verification Plan
  • Initiate Contract Manufacturer (CM) selection process
  • Develop design with manufacturing in mind (DFx)
  • Prototype, procure and test
  • Update and approve (release) documents including the DHF

    • Phase 3

  • Write protocols against specifications such as product and software
  • Execute dry runs, finalize, and approve protocols
  • Formally execute tests:
    • Functional
    • Safety
    • Transportation
    • Environmental etc.
  • Perform regression tests
  • Write verification reports
  • Finalize DHF
  • Perform controlled builds and create Device History Record (DHR)
  • Create a technical file for regulatory submission and certification

    • Phase 4

  • Write protocol and perform summative study (user study) to validate against the product requirements
    • i.e. built the right product
  • Assist regulatory group with technical documents

    • Phase 5

  • Develop manufacturing plan
  • Initiate transfer of technical information and documents to CM
  • Deliver Device Master Record (DMR)
  • Provide input to CM’s risk process
  • Assist in procurement, build and test instructions leading to New Product Introduction (NPI)

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