Medical Sterilization
Regulatory Compliance and Certification

Food and Drug Administration

Titan Scan facilities are subject to the same FDA audits experienced by our customers; therefore, Titan Scan is well aware of the FDA expectations of our customers as well as their expectations of a contract sterilizer.

Titan Service Centers are operated under the guidelines of Good Manufacturing Practices.

ISO 9002

ISO (International Organization for Standardization) is a worldwide federation of national standards bodies. The functions of the organization are performed by technical committees which are comprised of representatives from various countries who have an interest in the subject matter of the technical committee. Drafts of any standards proposed by a committee are circulated to all member bodies for voting and must obtain at least a 66% approval in order to pass.

ISO 9002 sets forth quality system requirements which can be used by a supplier to demonstrate its commitment to quality practices and capabilities. It also defines requirements for the assessment of accomplishment of those practices and capabilities by external parties who audit the supplier.

While certification by, and compliance with, ISO 9002 is voluntary in many countries, those companies who earn certification to this standard demonstrate their firm commitment to quality systems and their recognition of the needs of their own customers who might wish to earn certification. The Quality System models which are called out in ISO 9002 are detailed and highly comprehensive. Complying firms need to have given a great deal of time and personnel attention to quality system development in order to earn certification. All Titan Scan contract Service Centers are certified to ISO 9002.

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EN 46002

EN 46002 is a document prepared under the auspices of CEN, the joint European Standards Institution. Member countries of CEN include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. This document deals specifically with Quality Systems for medical devices and is based upon various standards including CGMP, ISO 9000, and the British Standard Institute documents on this subject. Compliance with, and certification to, this standard results in the granting to a manufacturer of a CE Mark which allows the manufacturer to sell products without further inspection to the member countries. Compliance with EN 46002 is mandatory in order to obtain a CE Mark, and CEN member countries are required to accept only products with the CE Mark in place. Thus, manufacturers and service providers worldwide who wish to sell into the CEN community must have the quality systems in place to comply with EN 46002.

EN552

In cooperation with EN 46002, which operates as the standards umbrella for sterilization activity, EN 552 sets forth specific guidelines and requirements for proper validation of radiation sterilization methodology.

Titan Scan Technologies was the first U.S. contract irradiation sterilization services provider to obtain both ISO 9002 and EN 46002 certification. The decision was made to pursue these certifications to demonstrate to Titan Scan's customers that we recognize their needs and challenges for the future. Titan Scan will continue to do everything in its power to support and assist manufacturers in the development of their own businesses with Titan Scan Technologies as an integral partner.

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