ISO 13485 Certification


ISO 13485 Certification vs QSR/21 CFR Part 820 Compliance

ISO 13485 is a series of requirements that help medical device manufacturers develop and maintain a quality management system (QMS). Its FDA counterpart is 21 CFR 820, also known as the quality system regulation (QSR), which defines current good manufacturing practices (cGMPs) for devices. 21 CFR Part 820 compliance is necessary for medical devices sold in the U.S., including imported products. ISO 13485 certification is voluntary in the U.S. but required in other many other countries. If a U.S.-based company intends to market its device internationally, it must comply with both the QSR and ISO 13485.

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History Behind ISO 13485 Certification

The standard, first published in 1986, was created to facilitate the harmonization of regulatory requirements for medical device makers on an international scale. Major revisions to the standard were published in 2003 and 2016. Just as ISO 13485:2003 rendered ISO 13485:1996 obsolete, ISO 13485:2016 replaces ISO 13485:2003. As with all ISO standards, existing ISO 13485 certification customers have three years to recertify to the latest version of the standard.

ISO 13485:2016 differs from ISO 13485:2003 in several ways. The biggest changes include:

  • Risk management must be applied to all quality process, not just design control
  • An increased focus on supplier controls and feedback
  • Increased clarification regarding validation, verification and design activities

Benefits of Obtaining 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

Obtaining ISO 13485 certification demonstrates the existence of an effective quality management system. It also makes it easier to conduct business in foreign markets and overcome many of the technical barriers to trade. Other benefits include:

  • Enhances company image in the eyes of customers, employees and shareholders
  • Satisfies contractual or regulatory requirements
  • Reduces risk and internal costs through increased efficiency and improved quality of operations
  • Provides a framework to introducing a culture of continuous quality improvement
  • Provides enhanced brand equity and marketing advantages
  • It’s the first-step toward achieving compliance with European, Canadian other regulatory requirements, as well as precursor to gaining entry into worldwide markets

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

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

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 obtain ISO 13485 certification because ISO standards are recognized worldwide.

How MasterControl Solutions Facilitate ISO 13485 Certification

MasterControl quality management software was designed to make it easier for medical device makers to obtain and maintain ISO 13485 certification. Moreover, MasterControl’s quality management suite was the first software solution specifically designed to comply with 21 CFR Part 820. Of course, device manufacturers selling in the global marketplace are also subject to other requirements, including EU Medical Device Directives and recommendations from the Global Harmonization Task Force (now maintained by the International Medical Device Regulators Forum). MasterControl helps manufacturers harmonize all of these relevant requirements in a single comprehensive quality system, making it easier to plan and prepare for FDA QSIT and Notified Body inspections and audits.

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. Best of all, 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 9001:2015 compliance. In fact, MasterControl can help companies meet the requirements of just about any ISO standard—and gain a competitive advantage in global markets.

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.