ECRM skills set in optical design and manufacturing made us a logical selection as a design and manufacturing partner for a medical device company that has developed a proprietary scanning technology that detects amblyopia or “lazy eye” in small children. Being ISO 13485 registered and meeting all related FDA requirements allowed us to partner in this exciting new product development. ECRM engineers worked closely with the customer R&D engineers to redesign a first level prototype to address cost, ergonomics and manufacturability. Custom alignment fixtures were designed as part of the project to assure quality, reliability and repeatability. Prototypes were built, tested and the product will be released for production in the fall of 2018.
ECRM has the expertise to design and manufacture a wide variety of medical devices. We have particular experience in optical scanning and imaging devices however our skills are very well suited to design a broad base of instrumentation. We offer an experienced work force focused on value engineering operating in an ISO13485 regulated environment.