Custom Device Development Pathway

Our robust product development process is ISO 13485 and 21 CFR 820 compliant and provides a rapid, effective pathway to commercialisation for our OEM partners.

Phase 1 & 2

  • Design, Prototyping & Pilot

    • Analysis of user requirements
    • Concept feasibility studies
    • Development of functional prototypes
    • Human factors research & user testing
    • Management of intellectual property

Phase 3 & 4

  • Verification & Validation

    • Clinical validation
    • Company-wide Quality Assurance
    • FMEA manufacturing process analysis
    • Design History Files (DHFs)
    • Device Master Records (DMRs)
    • Support with regulatory submissions

Product Launch & Rollout

  • Commercial Launch & Rollout

    • Full manufacturing process validation
    • High quality manufacturing & assembly facilities
    • Brand, packaging & marketing assistance
    • Post launch support