ISO 13485 Software Systems

ISO 13485 Software Helps Device Manufacturers Maintain a Compliant ISO 13485 System

The International Organization for Standardization (ISO) established the ISO 13485 standard to specify regulatory requirements for medical device manufacturers' quality processes. ISO 13485 gives medical device manufacturers a fundamental outline to follow so that they might better meet customer needs and industry compliance requirements. Achieving and maintaining ISO certification using manual processes is difficult, especially with the explicit risk requirements introduced in the 2016 revision of the standard. ISO 13485 software is designed to help medical device companies develop and maintain a compliant, risk-based automated ISO 13485 system.

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Key Requirements of a Robust ISO 13485 Software Solution

Medical device manufacturers face many challenges as they strive to comply with the ISO 13485 standard, officially titled ISO 13485-Quality Management Systems-Requirements for Regulatory Purposes. ISO 13485 compliance requires companies to establish satisfactory quality systems and to implement quality procedures that are properly documented, controlled, and maintained. An automated ISO 13485 system that relies on robust software tools, instead of manual processes, can help device organizations achieve their regulatory and business goals.

In order to meet the latest requirements put forth in ISO 13485:2016, device makers need an ISO 13485 software solution that offers these key features:

  • An Explorer tool for easy document search and retrieval. This is particularly important during certification audits when the registrar will assess how well a company's documented quality processes comply with the standard.
  • A risk management tool to help identify, minimize and track risks related to products, processes and services. According to the 2016 version of the standard, an ISO 13485 system must take a risk-based approach with all of its quality processes, not just design control. Unlike its predecessor, ISO 13485:2003, this requirement is explicit in ISO 13485:2016.
  • Due to the global nature of the medical device industry, outsourcing has become commonplace. ISO 13485:2016 expects manufacturers to maintain oversight of their entire supply chain. To meet this expectation, device companies will need to use ISO 13485 software that offers collaboration tools that allow manufacturers to easily communicate and collaborate with suppliers
  • The primary intent of ISO 13485 is, and has always been, to provide medical device manufacturers with a harmonized global structure for quality management. Therefore, it's important to choose ISO 13485 software tools that allow companies to build a fully integrated, configurable and connected ISO 13485 system.

Build a Compliant ISO 13485 System with MasterControl

If your company's quality management processes need improvement, MasterControl can help you build and maintain a compliant ISO 13485 system. MasterControl is a leading provider of quality management solutions and services to regulated companies around the globe. The comprehensive MasterControl ISO 13485 software suite is a leading quality management system that can streamline all quality processes. Hundreds of large and small medical device companies worldwide use MasterControl to manage quality processes and obtain the business and operational benefits of ISO certification. These benefits include increased customer confidence and retention; fewer deviations, nonconformances, recalls and regulatory sanctions; improved performance and supplier relationships; and increased speed to market.

Moreover, although ISO 13485 is a voluntary standard in the United States, medical device makers are required to comply with the US FDA Quality System Regulation (QSR) 21 CFR Part 820. MasterControl's quality management software suite was the first solution specifically designed to comply with 21 CFR Part 820.

MasterControl's Top 5 ISO 13485 Software Features

MasterControl offers device makers a comprehensive ISO 13485 software suite that unites multiple elements of the quality system under a single, comprehensive platform. Top features include:

  • Document Management: MasterControl software helps medical device companies comply with regulatory requirements by automating the routing, escalation, approval, and delivery of standard operating procedures (SOPs), policies and other documentation. The system provides automatic revision control to ensure that only the current version of an SOP is available. When a user makes a change to the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The system tracks these changes and makes them available through reports, which ultimately helps the organization meet the definition of a complaint ISO 13485 system.
  • Risk: Risk is mentioned 15 times in the 2016 revision of ISO 13485. Any actions taken by a business must be measures for controlling risk, which makes it imperative that device makers that opt to automate quality choose an ISO 13485 software solution with robust risk assessment and management capabilities. MasterControl users are able to evaluate different categories of operational risk and configure multiple risk types. Critical tools like risk assessments can be launched from anywhere with the system to analyze hazards associated with any process or activity. Risk mitigation and reassessment tools are also available to ensure a compliant ISO 13485 system.
  • Supplier Management: ISO 13485:2016 calls for increased supplier controls. MasterControl allows device makers to connect its supply chain management processes with other quality processes for a holistic approach to compliance. In addition, the MasterControl's Guest Connect add-on module can be incorporated into a company's supplier quality management system to give practical interaction capabilities with external suppliers, partners, and consultants, without giving them a full access account. This level of collaboration can dramatically increase efficiency and accelerate compliance.
  • Training: MasterControl's ISO 13485 software automates the assignment and monitoring of training tasks and grading of online exams. The software allows for training courses to be sequenced, so after a prerequisite is completed, the next course is automatically launched. The system also provides a group sign-off feature for verifying training of large groups of employees.
  • Audit: MasterControl's ISO 13485 system helps medical device manufactures comply with ISO 13485 by automating, streamlining, and effectively managing the audit process. The software provides advanced audit tracking capabilities, from scheduling and planning to execution and completion. MasterControl offers best practice forms for tracking basic audit information and audit findings. The system automates scheduling of all recurring audit-related activities and provides analytics and audit reporting capabilities for increased management visibility.

For More Information about ISO 13485 Software Solutions

To learn more about MasterControl's ISO 13485 Software Systems, please contact a MasterControl representative.