ISO 13485:2003, Quality Management Standard for Medical Devices is an ISO standard that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001 with some key differences:
the promotion and awareness of regulatory requirements as a management responsibility (an example of market specific regulatory requirements is 21 CFR 820 Quality System Regulation for Medical Devices sold in the United States)
controls in the work environment to ensure product safety
focus on risk management activities and design transfer activities during product development
specific requirements for inspection and traceability for medical devices
specific requirements for documentation and validation of processes for medical devices
specific requirements for verification of the effectiveness of corrective and preventive actions
Bryan Lubel, President Integron, said: “The addition of ISO13485 and ISO 9001 certification strengthens Integron’s commitment to customer quality and service and positions the company for further expansion in the medical device deployment services marketplace. This achievement provides our current and future customers a level of confidence and trust in Integron’s deployment and wireless services for medical devices.”