Company Description
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, and Ultrasound. 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 an ISO 13485 certified facility with FDA registration, including cleanroom capabilities.
Regulatory and quality system (QMS) consultants at StarFish provide technical regulatory assistance for FDA and Health Canada submissions, including IEC 60601 and ISO13485.
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