Sunoptic Technologies® manufactures Medical Devices in compliance with the current Good Manufacturing Practice (CGMP) requirements set forth in the FDA Quality System Regulation (QSR), Title 21 Part 820 of the Code of Federal Regulations. This QSR helps assure that medical devices are safe and effective for their intended use.
The QSR requires that specifications and controls be established for devices; that devices be designed and manufactured under a quality system to meet these specifications; that finished devices meet these specifications; be correctly installed, checked and serviced; that quality data be analyzed to identify and correct quality problems; and that complaints be processed. Basically, a quality management system must be established to cover design through servicing of a finished device and Sunoptic Technologies® has an effective system in place.
Sunoptic Technologies® is certified to ISO 13485:2016 “Medical devices – Quality management systems – Requirements for regulatory purposes” and ISO 9001:2015 “Quality management systems – Requirements.” Our focus is on the customer and our continual improvement of the quality management system will enhance customer satisfaction.