Quality Systems and Regulatory Compliance
Medical Indicators Quality Policy
Medical Indicators is committed to achieve Business Excellence while complying with all regulatory requirements. We will provide quality products, adopt continuous improvement methods and maintain the effectiveness of our quality system to ensure we meet customer expectations.
Medical Indicators Quality Systems Regulations and GMPS
At Medical Indicators, we have developed an integrated quality system based on the requirements of the ISO 13485 Quality System Standard and the FDA’s Quality System Regulation to meet Good Manufacturing Practices (GMP). Our facility is registered with the Food and Drug Administration (FDA) and complies with the latest requirements for medical devices.
Medical Indicators ISO Registration
Medical Indicators earned CE Mark certification to the Production Quality Assurance Standard in June of 1998. In March of 2008, the company obtained the certification to the ISO 13485 Medical Devices – Quality Management Systems – Requirements for regulatory purposes. The company is assessed annually from a notified body for conformance to these two standards.
At MII, we are committed to adhering to the highest compliance standards. Compliance is an essential part of who we are and how we do business and we take pride in that. We believe good compliance is simply good business. Therefore, our compliance department ensures to provide employees with clear guidance and education, so that they can appropriately navigate in today’s increasingly complex medical device regulated environment.