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ISO 13485 Software System

The ISO 13485 standard established by the International Organization for Standardization (ISO) specifies regulatory requirements for medical device manufacturers' quality processes. It provides a fundamental guideline for device makers’ quality compliance. ISO 13485 software helps device companies maintain an ISO 13485-compliant quality management system (QMS).

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The Importance of ISO 13485 QMS Software

As of March 1, 2018, all medical device certifications and certification renewals are required to align with the ISO 13485:2016 standard, which supersedes ISO 13485:2003. The standard was updated to adjust to technological advancements, modernized quality management practices and an increased regulatory focus on risk. The revision also specifies that any ISO 13485 quality system software in use must be validated and documented. Because a medical device’s success is reliant on the manufacturer’s ability to maintain quality compliance, a proven and efficiently validated ISO 13485 software system can be integral to a manufacturer’s ability to conform its quality practices to the latest requirements.

MasterControl ISO 13485 Software Features

  • ISO 13485 Document Control: MasterControl ISO 13485 document control software provides revision control and automates the routing, escalation, approval and delivery of standard operating procedures (SOPs), policies and other essential documentation.
  • Pragmatic Risk Management and Mitigation: In accordance with the risk-based approach explicitly outlined in ISO 13485:2016, MasterControl’s built-in risk management tools help identify, assess, control, minimize and track risks.
  • Compliant Audit Handling: MasterControl ISO 13485 quality system software automates, streamlines and effectively manages audit processes and incorporates best-practice forms for recording and tracking findings and other audit-related information.
  • Sequenced Training Administration: In addition to maintaining comprehensive training records, MasterControl’s ISO 13485 QMS software automates the assignment and monitoring of training tasks and sequentially launches courses or tasks when prerequisites are completed.
  • Connected Supplier Management: Answering ISO 13485:2016’s calls for increased supplier controls, MasterControl tightly connects supply chain processes to the overall quality system while providing secure interaction capabilities to suppliers and other external entities.
  • Comprehensive Quality Event Oversight: MasterControl integrates corrective and preventive action (CAPA) management with overall quality efforts and provides form-to-form launching capabilities (i.e., a CAPA form can be directly launched from a nonconformance report, etc.).

The Role of ISO 13485 Software in the Medical Device Industry

ISO 13485 compliance requires medical device manufacturers to establish satisfactory quality systems and implement quality processes that are properly documented, controlled and maintained. Reliable ISO 13485 document control software solutions allow companies to automate quality practices while providing a central repository for all quality documentation. What’s more, the increasingly global nature of the medical device industry demands the collaboration tools and supply chain oversight that ISO 13485 software systems afford. Proven ISO 13485 software systems not only streamline manufacturers’ processes and get products to market faster, they also accelerate and simplify validation activities and risk assessment/management.

ISO 13485 Software Requirements

To meet the current regulatory requirements set forth in ISO 13485:2016, device manufacturers need ISO 13485 quality system software that effectively helps them achieve their compliance goals by providing key capabilities such as:

  • Tools that simplify and accelerate document search and retrieval for auditors, registrars and other reviewers during certification audits or similar compliance initiatives.
  • Functionality that that supports the risk-based approach recommended in the standard by simplifying the identification, mitigation and management of risks.
  • Collaboration tools that facilitate effortless communication and collaboration between manufacturers and their suppliers, vendors and other external entities.
  • Functionalities that work in concert to form a harmonized universal structure for an integrated and configurable quality management system.
  • Proven methods for performing expeditious validation of the ISO 13485 quality system software in use.

ISO 13485 Software from MasterControl

For more than 25 years, MasterControl has been a leading provider of ISO 13485 quality system software to medical device manufacturers worldwide. Hundreds of medical device companies of all sizes around the globe use MasterControl ISO 13485 software to streamline and integrate quality processes. MasterControl accelerates the realization of the full business and operational benefits of ISO certification, such as:

  • Fewer deviations, nonconformances, recalls and regulatory sanctions
  • Strengthened and sustained customer confidence and retention
  • Enhanced supplier relationships and oversight
  • Improved ability to identify, evaluate, review and handle nonconforming materials, components, parts and finished products
  • Increased speed to market

MasterControl’s ISO 13485 document control capabilities allow device companies to automate the routing, escalation, approval and delivery of standard operating procedures (SOPs), policies and other compliance-critical information. The system also optimizes the management of audit and training programs as well as processes for handling quality events like nonconformances and CAPAs.

In alignment with the increased focus on validation highlighted in the revised ISO 13485:2016 standard, MasterControl provides the groundbreaking Validation Excellence Tool (VxT), an industry-first solution that enables companies required to conduct risk-based software validation to reduce validation times from months down to days or even hours.

FDA’s Perspective on ISO 13485 Software

The FDA’s stated mission of fostering medical device innovation reflects the pace of advancements in the modern technological era. The agency encourages the use of effectual electronic systems like ISO 13485 document control software solutions, provided the systems are appropriately validated in a manner that maximizes manufacturers’ avoidance of defects and resultant recalls. In fact, the FDA’s Office of Regulatory Affairs (ORA), the lead office for all FDA field activities, has used MasterControl since 2009 as the primary tool for its quality managers to uniformly apply and monitor work products and processes.