Optel, Inc., located in Rochester, New York, provides product design, manufacturing and regulatory compliance services for companies in the medical device market. Optel can take a product from concept through proof of principle, initial prototypes, pilot production samples, clinical trials, regulatory clearance and into volume manufacturing. The Company specializes in products that contain a complex mix of optical, electronic, mechanical, software and mobile app components. In addition, Optel will write your FDA QSR or ISO 13485 compliant quality system and document all product design and manufacturing processes as required by either or both of these medical device regulatory requirements. Optel’s team has extensive product design and manufacturing experience ranging from large systems to miniaturized handheld modules and devices.