The Metrix Company


	Committed to Quality. Our customers keep coming back because we maintain the highest quality standards with a deep commitment to service and support. This commitment is built on the strong foundation of our quality system, which is certified to ISO 9001 and ISO 13485. The Metrix Company is an FDA registered facility and we have the capabilities of manufacturing CE marked medical devices, for use in the European market. Our commitment to quality begins with the design phase and continues through to every aspect of the product life cycle. We strive to build quality into our products and to ensure this through a regimented process control and inspection process. Manufacturing is performed in controlled environments as we have three Class 8 cleanrooms which are certified to ISO 14644. We provide expertise and support to our customers on gamma irradiation, ethylene oxide and moist heat sterilization methods and process and product validations to AAMI/ANSI/ISO sterilization methods. As a customer, you will find our Quality Assurance Department to be indispensable in meeting all customer and regulatory requirements. If you require a Medical device to be sold within the United States: We are an FDA registered facility and we follow U.S. Food & Drug Administration Good Manufacturing Practices (GMP) for medical applications. If you require a Medical device to be sold within the European Union: Our quality system has been certified to Annex V of the European Union Medical Device Directive 93/42/EEC.