ISO 13485 Compliance

How ISO 13485 Compliance Provides a Framework for Meeting Medical Device Quality Standards

Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of ISO 13485 compliance and the FDA's 21 CFR Part 820 requirements is to ensure medical device quality, safety, and effectiveness.

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Why ISO 13485 Compliance is Important in Europe

Published in 2003, ISO 13485 compliance outlines the requirements for a comprehensive management system for the design and manufacture of medical devices. Complying with ISO 13485 is often seen as the first step in complying with European regulatory requirements. ISO conformance is important because the conformity of medical devices and in vitro diagnostic medical devices according to EEC Decrees 93/42/EEC, 90/385/EED and 98/79/EEC must be assessed before the sale of the medical device is allowed.

The preferred method to prove ISO 13485 compliance is the certification of the Quality Management System according to ISO 9001 and/or ISO 13485, ISO 13488, or ISO 14971 by a Conformity Assessment Body. A positive assessment is necessary for the authorization of the CE-identification and the permission to sell the medical device in the European Union.

Why ISO 13485 Compliance is Important in the US

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

Using Automation to Optimize ISO 13485 Compliance

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 ISO 13485 compliance.

For More Information About ISO 13485 Compliance

To learn more about ISO 13485 Compliance, or about any other ISO standard (e.g., ISO 9001, ISO 9001 2000, ISO 9000 2000, ISO 14000, ISO 14971, etc.), please feel free to contact a MasterControl representative.