IHT manufactures Class IIa medical devices. These are regulated by the United States Food and Drug Administration (FDA). Our machines are GSR (Galvanic Skin Response) devices for Meridian Stress Assessment. As such, we are under specific mandates to perform to certain measurable criteria that is established, updated, monitored, audited and enforced by the FDA.
We are required to operate under an FDA 510 (K) registration. We are required to validate the safety and effectiveness of our products. We are required to establish and maintain a Quality System. We must comply with current MDR (Medical Device Reporting) regulations. Over and above this and other mandatory regulations we choose to test our products to the highest standards set by governments the world over. Below and in the links provided you will find specific information regarding these types of regulatory requirements that sets IHT apart as an industry leader.
The United States Food and Drug Administration (FDA) determines and regulates the status and classification of all medical devices that are sold in the United States. Individuals and companies cannot, of themselves, determine if their device is medical or non-medical, nor can they decide what classification, if any, a device falls into. IHT's current line of GSR (Galvanic Skin Response) devices are regulated and fall into a Class IIa medical category. It was necessary for us to apply for and be granted an FDA 510 (K) market clearance. This allows us to market our devices, with certain restrictions, here in the US. Our 510 (K) is only the first step. There are many other requirements we and any manufacturer, must continually meet.
Once the FDA has approved or allowed the use of a medical device in the US market, they have established a comprehensive set of standards that manufacturers must adhere to. These requirements or procedures are mandatory and enforceable by the FDA. This is an ever evolving set of instructions that all manufacturers must understand, implement and live by. The FDA can audit any manufacturer at any time and determine how well these rules are being followed. The FDA has the right to require corrective action on the part of a device manufacturer to ensure that these standards are adhered to. The FDA can enforce recalls, effect changes and in extreme cases demand the seizure of product or revoke the manufacturer's ability to sell. IHT is constantly striving to maintain, expand and perfect these on-going standards.
To meet many of the requirements of the FDA's Quality System it is necessary to have medical devices tested by outside, third party, accredited facilities. The extent of testing required depends on the classification of the device. In the case of the products manufactured by IHT, the testing is extensive. We are required to pass safety issues, radiated emissions, air discharge tests, contact discharge tests, electromagnetic field tests, power frequency tests and a host of others. These tests are time consuming and expensive, often taking months and costing vast amounts of capital. IHT not only complies with these requirements here in the US, but often exceeds them, as we also test for stringent requirements on the world stage.
IHT also sells its products in foreign markets. Many of the requirements that the FDA mandates here in the US are also mandatory abroad. There are also requirements that go beyond the US procedures. The most common is called the CE mark. There are currently 24 countries around the globe that require the CE mark on any product sold within their borders. IHT meets these requirements and currently has passed all the testing and has a CE mark on all of its products. Moreover, many nations that are not part of the CE mark with the European community, are part of a program called the CB Scheme. This means that many, if not all, of the test requirements for these countries fall within the procedures needed for the CE mark. This makes IHT a truly globally compliant company, with the ability to sell in literally any market. This gives extra assurance to you, the customer, that we manufacture to world class standards.
IHT is pleased to announce it has received certification from Orion Registrar, Inc. USA for ISO 9001:2000. The company achieved this goal on September 29th, 2005 thus adding to our list of international certifications. To see a copy of this certificate click here.
The term ISO is heard a lot. It stands for International Standards Organization. This group sets up manufacturing standards and procedures to ensure consistency in product production and to establish a system for determining and checking the quality of any given product. IHT requires its key product vendors to be certified to these high international procedures. The primary hardware piece in all of the products we sell is the electronics. All of our electronic components are manufactured to the latest ISO standard. Our current main electronics vendor is Newonics, located in the state of Utah. At our insistence, other key vendors are in the process of completing their individual ISO testing and are on target to be certified this year.
Meeting the FDA's Quality System Requirements (Good Manufacturing Procedures) goes beyond testing products for compliance in the US and abroad. It means that companies must have an acceptable Quality Assurance system in place that meets specific FDA requirements. It means that we must implement and use this system on a daily basis. It includes, but is not limited to, the following items: device design specifications, product labeling, packaging specs, policy objectives, management responsibility, quality plan, quality audits, design review, design validation, document control, purchasing controls, approved vendors, inspection, corrective and preventative action, etc. Everyone at HT plays a role in the Quality System. Everyone, from management to the smallest vendor, is responsible and proud to build the finest quality product.
Tracking and solving problems and questions that come up in the field is more than a good way to do business. The FDA makes it mandatory that we have an effective and approved method for Corrective and Preventative Action. This means that we record ALL customer calls that come in. We then routinely review and analyze these records to see if there are any patterns or incidences that indicate problems that need to be addressed immediately or in the long term. The first response is to correct any problem in the field as fast as possible, so our customers can use our products safely, consistently and effectively. The second tier is to correct future problems before they occur. This is an on-going task of the IHT Development team and management. Weekly development meetings focus on ways to improve product performance and reliability in real-world field applications. On-going development and research look for long term answers and new technologies that will make our products more effective, easier to use, more reliable, and more affordable.