Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of ISO 13485 compliance is to ensure the quality, safety and effectiveness of medical devices. The ISO 13485 standard is a series of requirements that help device makers develop a quality management system. According to ISO, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. The publication of the 2016 version of ISO 13485 allows manufacturers that currently meet the requirements of ISO 13485 compliance three years to transition from ISO 13485:2003 to ISO 13485:2016.
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Although ISO 13485 compliance is voluntary in the United States, it provides a framework for meeting medical device quality requirements in international markets. ISO 13485 compliance also helps meet the requirements outlined in the FDA’s 21 CFR Part 820 for the Quality System Regulations (also known as QSR and cGMP), which is applicable to medical device manufacturers and importers. In the U.S., compliance to FDA QSR is required. Any U.S.-based company that wishes to market its medical device products globally must comply with both 21 CFR Part 820 and ISO 13485.
While ISO 13485 compliance is also voluntary in Europe, it 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. ISO 13485 certification allows devices makers to meet the aforementioned EEC Decrees with less difficulty, which expedites market entry.
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.
Unlike Europe and the U.S., ISO 13485 compliance is compulsory in both Canada and Japan. Conformance to ISO 13485 is necessary in order to secure a Canadian Medical Device License for Canadian class II, III or IV medical device. Japanese Ministry of Health, Labour and Welfare (MHLW) Ordinance #169 is based on ISO 13485, and it is required in Japan.
Even in countries where ISO 13485 compliance is not mandatory, it is expected by investors, partners and customers. A 2011 survey of 900 ISO 13485-certified medical device manufacturers showed that 28% of respondents had become certified not because it was required by law but because it was required by their customers. Third-party certification to ISO 13485, as well as other ISO medical device standards, assures customers, prospective customers, suppliers and foreign trade officials that a company’s operations are safe and effective. What’s more, the marketing and business advantages of ISO 13485 compliance are substantial.
There are many benefits a medical device company may gain from ISO 13485 compliance, including:
According to Quality Digest, many companies striving to achieve ISO 13485 compliance continue to prepare for or maintain ISO registration using manual processes, which are time consuming and prone to error. Manual registrations are also expensive; they cost more than $100,000, and, on average, take up to 12 months to prepare. Moreover, many companies, as much as 50 percent, will fail to recertify because they were not able to maintain and scale their manual processes.
When you imagine the amount of time it takes to key in or type the required quality documents, locate paperwork and manually compare the data to the information provided in the application, it’s easy to see the disadvantages of attempting ISO certification in a manual environment. 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 and maintaining certification.
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.