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21 CFR Part 820 compliance is necessary for medical devices sold in the U.S., while ISO 13485 certification is necessary for medical device manufacturers who sell their products in the international market. To learn about other differences between the requirements of 21 CFR Part 820 compliance and ISO 13485 certification, please download the Question-Answer article below.
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MasterControl Inc., a pioneer in developing quality management software for companies in FDA and ISO environments, prepared this question-and-answer article, which compares the quality-related requirements of 21 CFR Part 820 with ISO 13485, and provides a detailed analysis of the differences.
Although ISO 13485 and 21 CFR Part 820 are similar, they have significant differences. For example, in the case of complaint handling and reporting, ISO 13485 certification would not be sufficient to meet the requirements of 21 CFR Part 820.
However, as noted above, medical device manufacturers that sell their products in the global market would find it advantageous to get ISO 13485 certification because ISO standards are recognized worldwide.
Developed over a decade ago, MasterControl quality management software was the first software solution specifically designed to help companies get ISO 13485 certification and comply with 21 CFR Part 820.
The MasterControl quality management suite consists of configurable, easy-to-use, and connected applications. The suite helps companies meet the requirements of ISO 13485 certification and 21 CFR Part 820 by automating, streamlining, and effectively managing the following applications: document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and forms-based quality and business processes. And MasterControl does it all under a single Web-based platform.
In addition to helping companies with ISO 13485 certification, MasterControl helps companies with ISO 14000 certification, and with ISO 14971 compliance, and ISO 9001 2000 compliance. In fact, MasterControl can help companies meet the requirements of just about any ISO standard.
To learn more about how MasterControl solutions can facilitate ISO 13485 certification as well as compliance with regulatory requirements, please feel free to contact a MasterControl representative.