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ISO 13485 specifies requirements for a quality management system (QMS) in the medical device industry. Seal supports medical device companies in meeting these requirements through built-in document control, version management, audit trails, and training management. Contact [email protected] for validation templates and implementation support.
Section 4 outlines the general requirements for establishing a QMS, emphasising the need for a documented system that defines processes, identifies resource needs, and manages the interactions required to achieve quality objectives.Additionally, organisations should address elements such as risk management, process approaches, and implement controls to ensure compliance with regulatory standards. This foundational section sets the framework for consistent quality across all areas of the medical device lifecycle, from design to distribution.Seal facilitates the various aspects of document management, such as process tracking, risk management, and version control to support the lifecycle of medical device products, from development to distribution. Seal enables the ability to execute controls such as (but not limited to):
  • Reviewing and approving documents
  • Displaying status of documents and enabling relevant versions of applicable documents to be available at points of use
  • Legible and readily identifiable
  • Detailed audit trail
  • System is maintained to provide evidence of conformity to requirements and of the effective operation of the QMS
Section 5 emphasises the role of top management in establishing, implementing, and maintaining an effective QMS for medical devices. This section covers several critical aspects, such as:
  • Quality policy, objectives, and planning
  • Responsibility, authority, and communication
  • Management review
Section 5 ensures that management is accountable and actively involved in promoting a culture of quality, risk management, and regulatory compliance.Seal supports these leadership functions by enabling management to maintain accountability and compliance with ISO 13485 requirements by providing the appropriate tools within the Seal platform to configure to quality objectives that align with regulatory and customer requirements.Workspaces enable clear divisions between user groups and can be configured to assign responsibility to specific users.
Section 6 details requirements for ensuring that an organisation focuses on the provision of resources, such as personnel, infrastructure, and working environment. Organisations should also ensure necessary competencies of personnel, provide training as needed, and evaluate the effectiveness of these activities.Seal helps organisations manage personnel, infrastructure, and work environments. Workflows and dashboards track staff competencies and certifications. Training Management stores all training records for current and past users.
Section 7 details requirements for the processes involved in bringing a medical device from concept to market. This section outlines critical areas to ensure product quality, safety, and regulatory compliance, such as:
  • Planning of product realisation
  • Customer-related processes
  • Design and development
  • Purchasing controls
  • Production and service provision
Seal can be configured to mandate systematic monitoring and feedback handling, enabling proactive quality and compliance management throughout the device lifecycle.
Section 8 defines processes for monitoring, measuring, analyzing, and improving the QMS to ensure continual compliance and product quality. This includes components such as:
  • Feedback and complaint handling
  • Internal audits
  • Monitoring and measurement of processes and product
  • Analysis of data
  • Improvement
Seal supports continuous improvement through systematic monitoring, feedback handling, and data analysis—enabling proactive quality management.