The new article provides additional details regarding the quality management system, explaining how it should be implemented in software medical devices.
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The Health Sciences Authority (HSA), Singapore’s regulatory agency in healthcare products, has published a guidance document dedicated to software medical devices in the context of a life cycle approach.
The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be considered by medical device manufacturers (software developers) to ensure compliance with it.
At the same time, the authority reserves the right to change the guidance and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Quality Management Systems in Software Medical Devices: Introduction
The rapid technology development in medical devices with a wide use of software solutions creates a need for a clear and robust regulatory framework to ensure these products’ quality, safety, and effectiveness.
According to the guidance, the Quality Management System (QMS) is necessary for manufacturers of all medical devices, including software-based ones, to maintain manufacturing quality and consistency.
The relevant international standard ISO 13485 outlines the requirements for a QMS tailored to regulatory purposes, emphasizing the importance of good software quality and engineering practices in controlling software product quality.
Core Principles of a QMS for Software Medical Devices
The document further outlines the main principles to be followed in software products. As explained by the HSA, an effective QMS complies with several key principles:
- Leadership and Organizational Structure: Essential for providing the governance and management support necessary for quality assurance.
- Lifecycle Supported Processes: Product planning, risk management, documentation, and more are vital across all stages of product realization.
- Product Realization Activities: From defining requirements to decommissioning, these activities follow the software engineering life cycle approach, ensuring comprehensive quality control.
Adopting and implementing a QMS are strategic decisions that reflect an organization’s specific needs, objectives, product types, processes, and organizational structure.
Leadership and Organizational Support
According to the guidance, the basis of a successful QMS lies in strong leadership and organizational support, focusing on strategic direction, defining roles and responsibilities, and ensuring resource availability.
This includes competent personnel, infrastructure, tools, and a conducive environment for the software medical device’s development and maintenance.
Lifecycle Supported Processes
For software medical devices, the lifecycle-supported processes form the critical element of the QMS, covering such aspects as:
- Product Planning: Dynamic and adaptable to new information and milestones.
- Risk Management: Integrating a risk-based approach for patient safety throughout the device’s lifecycle.
- Documentation and Record Control: Ensuring evidence of compliance and quality through documentation and record-keeping.
- Configuration Management and Control: Maintaining software integrity and traceability throughout its lifecycle.
- Measurement, Analysis, and Improvement: Evaluating the software’s effectiveness and implementing improvements based on data analysis.
- Outsource Management: Ensuring control over outsourced processes to maintain product safety and performance.
Product Realization Activities
As further explained by the authority, one of the most critical aspects of the QMS principles is the concept of product realization activities supported by leadership and lifecycle processes.
These activities incorporate risk assessment and mitigation at every stage, emphasizing:
- Defining Requirements: Aligning with the intended use and considering all user, patient, and regulatory needs.
- Design and Development: Focusing on architecture, components, and integration while considering clinical and home use environments.
- Verification and Validation: Ensuring the software meets its intended use and design requirements through thorough testing.
- Deployment or Implementation: Secure and reliable delivery and setup of the software.
- Maintenance and Servicing: Responding to user requirements changes and maintaining the integrity and safety of the software.
- Decommissioning: Controlled termination of the software, ensuring the safety of patient data and minimizing public health impacts.
Conclusion
The present guidance additionally emphasizes that integrating a QMS in developing and maintaining software medical devices is a critical step toward ensuring their quality, safety, and effectiveness. By adhering to the principles outlined in ISO 13485 and focusing on comprehensive lifecycle processes and product realization activities, manufacturers can establish a solid foundation for delivering high-quality medical devices.
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