Medical Indicators Quality Policy
Our Promise to You
Medical Indicators is committed to achieving 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
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.
We also implement quarterly testing of our production facilities, as well as routine testing of all our products.
Safety
To ensure the safety of our thermometers, we test all of our thermometers for bioburdens via two forms of testing: sterility testing (for sterile products) and bioburden testing (for standard products).
Medical Indicators ISO Registration
Medical Indicators earned our CE Mark certification to the Production Quality Assurance Standard in June of 1998. In March of 2008, our company obtained its certification to the ISO 13485 Medical Devices—Quality Management Systems—Requirements for regulatory purposes. We are assessed annually from a notified body for conformance to these standards and regulations.
View Our Certifications:
