ISO 13485 Certification

Find Out How ISO 13485 Certification Differs from 21 CFR Part 820 Compliance

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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	Product Data Sheet: MasterControl Audit™
	White Paper: Six Ways to Optimize Your Quality Management System and Ensure FDA and ISO Compliance
	Q&A: Compliance with 21 CFR 820 and ISO 13485 Using MasterControl
	Interactive and Live Demonstration: MasterControl Quality Suite Demonstration
	White Paper: The Basics of ISO 13485
	White Paper: cGMP and ISO 13485 Integrated Quality Management System
	White Paper: Meeting ISO 9001:2008 - Standards with Automated Tools
	Product Data Sheet: MasterControl QMS and QEM Systems for ISO Guided Companies
	White Paper: Ten Signs Your CEO Still Has No Idea About ISO 9001 and Lean

Question-and-Answer Article about ISO 13485 Certification and 21 CFR Part 820

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.

Does ISO 13485 Certification Meet all the Requirements of 21 CFR Part 820?

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.

How MasterControl can Help in Achieving ISO 13485 Certification

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.

MasterControl Quality Management Suite for ISO 13485 Certification

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.

For More Information on ISO 13485 Certification

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.