Research and Development:
Quality and Compliance First
Medical Indicators, Inc. is committed to providing quality products with clinical accuracy that are
up to the highest infection control standard. MII adopts continuous improvement methods to
maintain the effectiveness of our quality system and product development.
up to the highest infection control standard. MII adopts continuous improvement methods to
maintain the effectiveness of our quality system and product development.
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.
Compliance
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.
Product Development
Precision Temperature Measurement Solutions
Medical Indicators, Inc. is a FDA registered and ISO 13485 certified manufacturing facility located in Hamilton, New Jersey producing over 100 million precision temperature measurement solutions per year. Whether it’s NexTemp, TempaDOT or TraxIt, we have a precision thermometer that meets your unique temperature measurement requirements.
Precision Built In
The manufacturing process starts with our patented chemistry system. Each dot on our thermometers contains a unique formulation of chemistry that’s designed to react at a specific temperature. That means for a single thermometer, we have 45 unique Fahrenheit mixtures, 50 unique Celsius mixtures, or 70 unique TraxIt mixtures which have been custom formulated to activate at each specific temperature point.
The Testing Process
Every lot of NexTemp, TempaDOT or TraxIt thermometers undergoes a two stage precision accuracy testing process. The first stage of accuracy testing occurs when the thermometers are initially manufactured. Medical Indicators performs random sampling for in-process roll accuracy testing and we test in our calibrated, precision water baths to ensure that their performance meets our rigid Quality Control requirements.
A second accuracy test is performed when the thermometers are packaged. Thermometers are randomly sampled at a 1.5% AQL, based upon lot size, tested in precision water baths which have been customized to meet our stringent accuracy needs. All accuracy results are compared to the requirements of nationally or internationally recognized testing standards (Table 1.) before the thermometers are released for sale.
Accuracy requirements of recognized testing Standards
Throughout the manufacturing and packaging processes, trained operators are constantly monitoring the processes to ensure good quality of products that meet customer satisfaction are being produced.
| Critical Range (°F) | Allowable Deviation | Critical Range (°C) | Allowable Deviation | |
|---|---|---|---|---|
| ASTM E 1299 | 98.0 – 102.0 °F | ± 0.2 °F | 37.0 – 39.0 | ± 0.1 °C |
| ASTM E 825 | 98.0 – 102.0 °F | ± 0.2 °F | 37.0 – 39.0 | ± 0.1 °C |
| BS EN 12470-2 | N/A | N/A | 35.5 – 40.4 °C | + 0.1/- 0.2 °C |