ISO 13485 Medical Devices

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) in the medical device industry, with the focus to ensure that medical devices consistently meet customer and regulatory requirements to enhance safety and effectiveness throughout the product lifecycle.

This page offers a brief overview of the technical functionalities that satisfy the above requirements. It does not delve into comprehensive details, or serve as legal counsel for achieving absolute compliance.

Seal can provide support and templates to help our clients validate and be compliant to ISO 13485 - email [e-mail] to find out more.

Quality Management System

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

Seal is not responsible for ensuring documented statements of quality policies or procedures required by this International Standard.

Management Responsibility

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.

Additionally, Seal’s workspaces allow clear divisions of user groups across the organisation and can be configured to enable responsibility in relevant users.

Seal is not responsible for ensuring documented statements of policies or procedures required by this International Standard.

Resource Management

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 peronnel, provide training as needed, and evaluate the effectiveness of these activities.

Seal supports the above by helping organisations effectively manage personnel, infrastructure, and work environments. Processes, workflows, and dashboards can be set up to track staff competencies and certifications, as well as for planning purposes. Seal’s Training Management also enables efficient tracking of training within the organisation, storing all training records of current and past users.

Seal is not responsible for the setting up of such workflows, or providing resources beyond the means of the platform.

Product Realisation

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 facilitate continuous improvement by mandating systematic monitoring, feedback handling, ensuring that the organisation can proactively manage and enhance quality and compliance for its medical devices.

Seal is not responsible for setting up of such workflows or dashboards, or providing resources (such as documentation) beyond the means of the platform. Additionally, it is not responsible for ensuring that every step in product development, from design through manufacturing to customer delivery is compliant throughout the device lifecycle.

Measurement, Analysis and Improvement

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 can be configured to facilitate continuous improvement by mandating systematic monitoring, feedback handling, to ensure that the organisation can proactively manage and enhance quality and compliance for its medical devices.

Seal is not responsible for setting up of such workflows or dashboards, or providing resources (such as documentation) beyond the means of the platform. Additionally, Seal is not responsible for the monitoring of these components.