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ISO Medical Device Standards

ISO 13485 and ISO 14971, sometimes referred to as ISO medical device standards, are two of the most relevant and widely recognized standards for producing med devices. Adhering to these standards is voluntary, but even countries that enforce obligatory regulations – such as those set forth by the U.S. FDA – encourage and expect med device manufacturers to follow them as a matter of good manufacturing and business practice.

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Medical Device Standard Updates

Due to the changing nature of the industry, ISO medical device standards are reviewed every five years to determine if a revision is required. First released in 2003, the quality management system standard for med devices has since been updated to ISO 13485:2016. ISO 14971:2007 is the current version of the risk management standard for med devices.

While not mandatory, ISO standards serve as a framework for obtaining compliance with various regulatory and customer requirements. Companies that adhere to these standards are typically better equipped to bring their products to international markets more quickly and effectively than their competitors thanks to streamlined and risk-averse processes, ultimately resulting in a more profitable business.

Overview of Current ISO Medical Standards

  • ISO 13485:2016 focuses on the establishment and implementation of a quality management system. It builds on the industry-neutral ISO 9001 standard, refining it for med device and aiming to harmonize with the applicable regulatory requirements specific to that industry.
  • ISO 14971:2007 provides risk management guidelines that apply specifically to med devices. Together, ISO 14971 and ISO 13485 offer solid guidance on how manufacturers can produce safe and effective products.
  • I SO 9001:2015 is the general standard for quality management that guides companies in any industry to implement a robust quality management system for continuous improvement by engaging management throughout the quality control process.
  • ISO 14001:2015 defines the requirements and guidance for an environmental management system, helping companies manage their impact on the external environment, reduce pollution and comply with related regulations.
  • ISO 45001:2018 outlines requirements for occupational health and safety management systems that help to ensure a safe and healthy workplace for employees while maintaining productivity and scalability.
  • ISO/IEC 27001:2013 provides tools and protocols that help companies protect their information and intellectual property by assessing, preventing and managing physical security and cybersecurity risks, threats or breaches.

Risk Management Principles

ISO medical device standards provide a collective framework for managing various types of risk to your company. Essential to this endeavor is the practice of risk analysis, which establishes a process for managing and controlling product risk. Risk analysis must be performed for each med device produced, and includes the documentation of intended use of each product and the product characteristics that could affect safety. Risk control is also a critical aspect of risk management, as it determines criteria for what the acceptable levels of risk are for your company, and how to handle risk within those limits.

MasterControl Features

MasterControl quality and compliance software helps companies throughout the world in adhering to ISO medical device standards and complying with FDA regulations, EU directives and other regulatory requirements.

  • Quality Management:MasterControl’s end-to-end solution automates and connects all quality processes critical to ISO conformance and regulatory compliance, including document control with MasterControl Documents™.
  • Training Management: MasterControl Training™ addresses training control requirements under ISO medical device standards and various regulations, helping companies manage the training process more effectively.
  • Quality Event Management: MasterControl CAPA™ is integrated with all quality processes so the system can track any quality issues that could potentially escalate to CAPA.
  • Audit Management: MasterControl Audit™ streamlines the audit process by automating all recurring audit tasks, gathering basic audit information, and tracking audit findings.

Achieve ISO Medical Device Standard Certification With MasterControl

Medical device standards are dependent on the establishment of a quality management system, including quality procedures that are documented, controlled, implemented and maintained according to applicable guidelines and requirements. MasterControl provides a web-based digital platform and fully integrated solutions for your company's quality management system.

MasterControl Quality Excellence™ is a robust software suite that automates routing, review and approval of documents, provides a central repository for all critical documents, and performs automatic revision control, so only the current version of SOPs and other documents are available in the system. It helps manage critical elements of the training process by automating the assignment of training tasks, distribution of training materials, testing and verification. A risk-based approach to quality management, as emphasized in ISO medical device standards, is also easy to adopt and implement with MasterControl’s dedicated risk management functionality, including tracking of all risk management activities, electronic workflows, risk assessment forms, and analytics and reporting tools.

Trusted Software Provider

Choosing MasterControl means choosing a software solution that exceeds the rigorous demands of auditors and regulators themselves. The FDA entrusts its own quality processes to MasterControl, with two of its divisions using MasterControl as their quality management system for document management, training, change control and more. To learn more, contact MasterControl today.