Masako Hegge

StarFish Medical provides award-winning design, development, and flexible manufacturing outsourcing services —100% dedicated to the medical device and life science marketplace. StarFish partners with innovative companies to create and manufacture breakthrough products for a full range of medical specialty areas including: Cardiovascular, Digital Health, IVD, Ophthalmology, Optics, Ultrasound, POC Assay Diagnostic Technologies, and Microfluidics. StarFish expertise includes electronics, mechanical, human factors and software systems engineering. Our proprietary Pathfinder™ process for medical device product definition saves clients time and resources throughout the technology and product development phases to commercialization. Prototype and low volume complex electro-mechanical production are delivered in ISO 13485 certified facilities with cleanroom capabilities in Toronto and Victoria Regulatory and quality system (QMS) consultants at StarFish provide technical regulatory assistance for FDA and Health Canada submissions, including IEC 60601 and ISO13485. Innovative Design and Development  Electronic / software / mechanical engineering  Industrial design / human factors engineering  PathfinderTM product definition process  Technology optimization  Verification / validation / testing  ISO 13485 certified QMS Integrated Manufacturing  Seamless ramp from clinical trials to full production  Deep engineering involvement & oversight  Electro-mechanical / software expertise  Customized cart specialists  Optical instrument build and test  Dedicated program manager Flexible Manufacturing  New product introductions  Supply-chain management  North America facilities  Depot repair & field service  Sustaining / value engineering  Class 100,000 cleanroom