Our FDA inspected, CAN/CSA and ISO 13485 certified quality management system structures all company activities. Core functions and capabilities include compliance with FDA, ISO 13485; CMCAS requirements and other relevant standards; CGMP trained quality assurance engineers and inspectors; qualification, evaluation and control of suppliers; failure and hazard analysis for products; equipment calibration and specification of tooling and equipment; and CAPA for product defects and system failures.
Provide comprehensive solutions for medical device industry through delivery of customer responsive development, regulatory, and manufacturing services that exceed customer expectations and comply with regulatory requirements while continuously improving the effectiveness or our quality management system.
projects are supported by the eu
