ISO 13485 Standards

White Paper Describes How ISO 13485 Standards Provide the Framework for Medical Device Compliance Internationally

ISO 13485 standards are a group of international standards for medical device manufacturers. The main goal of the ISO 13485 standards is to provide a harmonized model for quality management system requirements in the international market. (Note that ISO 13485 2003 has replaced ISO 13485 1996.)

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The preferred method for proving conformity is the certification of the Quality Management System according to ISO 9001 2000 and/or ISO 13485 standards, ISO 13488, or ISO 14971 by a Conformity Assessment Body (CAB). A positive assessment is needed for authorization of the CE-identification and the permission to sell a medical device in the European Union.

Why is Compliance to ISO 13485 Standards Important in the U.S.?

Although in the U.S. ISO 13485 Standards, compliance is voluntary, it provides a framework for meeting medical device quality requirements in the international market. Compliance with ISO 13485 standards also helps meet the requirements specified in 21 CFR Part 820 for the Quality System Regulations (QSR) applicable to medical device manufacturers and importers.

How can Automation Facilitate Compliance to ISO 13485 Standards?

Through efficient process management, medical device companies can achieve increased efficiency, higher performance, and reduce their operational costs. Transforming manual processes into automated processes in areas such a document control and process management can provide dramatic results in terms of assuring compliance to ISO 13485 standards.

Why is Compliance to ISO 13485 Standards Important in Europe?

ISO 13485 outlines the requirements for a comprehensive management system for the design and manufacture of medical devices. Compliance with ISO 13485 standards is often seen as the first step in complying with European regulatory requirements. The conformity of medical devices, as well as in vitro diagnostic devices, must be assessed before the sale of the medical device can commence (see EEC Decrees 93/42/EEC, 90/385/EED and 98/79/EEC).

For More Information on ISO 13485 Standards

For more information about ISO 13485, or about how MasterControl can streamline compliance to ISO 13485 standards, please contact a MasterControl representative