PROJECT – Drug Delivery System (Class II)
— Injection Mechanism Tested via ISO 21649
— Injection Molded Case
— Spring Loaded Charge
— Pressure Rating and Testing
Dosage Delivery Mechanism Design — Verification/Validation Protocols — Packaging Design — Life Cycle Lab Testing — Cadaver Testing — Sterilization Process
A customer was seeking expansion into the US market from initial success overseas and required design changes to meet FDA regulatory requirements. Singularis provided guidance on high level strategy based on current device design and available data, identified key vendors for lab testing, and designed and generated the verification and validation protocols intended for FDA submission. The client also utilized Singularis to investigate spin off markets for the product in the veterinary and dental industries.