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What is the ISO 13485 Standard?

The ISO 13485 standard, established by the International Organization for Standardization (ISO), is a set of internationally-recognized quality management system requirements. The standard includes guidelines that apply specifically to medical device development, such as design control, risk mitigation, and supply chain management.

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Automation Facilitates Compliance to the ISO 13485 Standard

Compliance with the quality system regulations requires operational efficiency, significant attention to detail, and minimal errors. Automating quality processes, such as document control, increases process efficiency and accelerates regulatory compliance.

Why the ISO 13485 Standard is Important for US and Europe

  • Provides a framework for meeting medical device quality requirements in international markets.
  • Compliance with ISO 13485 helps companies meet the requirements specified in 21 CFR Part 820 for quality system regulations.
  • Helps companies maintain efficient and holistic quality management processes.
  • Compliance with ISO 13485 is often seen as the first step in complying with European regulatory standards.
  • Meets the individual needs of varying types of medical device manufacturers to fulfill regulatory requirements.
  • Reflects a strong commitment to continuous improvement in developing safe and effective medical devices.

Who is ISO 13485 for?

The ISO 13485 standard is designed for organizations involved in designing, developing, installing, and servicing medical devices to demonstrate compliance with regulatory requirements. It can also be used by internal and external auditors to help with ISO auditing processes.

ISO 13485 Standard Requirements

The ISO 13485 standard includes requirements for a quality management system where a medical device manufacturer needs to demonstrate its ability to consistently develop medical devices that meet applicable regulatory requirements. Some of the key requirements of an organization’s quality management system include:

  • Quality policy, quality manual, and quality objectives.
  • Document and record control procedures.
  • Corrective and preventive actions.
  • Employee training.
  • Supplier controls.

Successful ISO 13485 Compliance Begins with MasterControl

MasterControl’s quality management solutions enable companies to integrate and streamline all quality processes to more easily comply with FDA regulations and the ISO 13485 standard. Automating your quality management processes improves your operational efficiency, reduces costs, and accelerates your time to market.

FDA Uses MasterControl

MasterControl solutions are used by the most trusted leaders in life sciences and manufacturing industries, including the U.S. Food and Drug Administration (FDA). Since 2009, the FDA’s Office of Regulatory Affairs (ORA) has been using a variety of MasterControl’s Quality Excellence™ solutions across all of its business units.