Custom Device Development Pathway

Our robust product development process is ISO13485 & 21 CFR 820 based and therefore provides a rapid and effective pathway to commercialisation for our OEM partners.

Custom Development Pathway Diagram

Phase 1 & 2: Design, Prototyping & Pilot Production
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
Phase 5: Commercial Launch & Rollout
Full manufacturing process validation
High quality manufacturing & assembly facilities
Brand, packaging & marketing assistance
Post launch support