A medical device quality management system (QMS) is a structured system of procedures and processes covering all aspects of design, manufacturing, supplier management, risk management, complaint handling, clinical data, storage, distribution, product labeling, and more.
The purpose of QMS is to improve the quality of medical devices and related services, and constantly meet customer and regulatory requirements.
International regulations governing a medical device QMS
Nearly every major market requires the implementation and maintenance of a quality management system as a condition of product registration. Device manufacturers in Europe tend to follow the ISO 13485 standard, while US companies comply with the US FDA’s Quality System Regulation (QSR).
Key benefits of medical devices QMS
• Reduced market time for devices
• Deep root cause analysis in case of any error
• Adaptability in compliance with industry regulations
• Eradication of non-value added and waste activities
• Improved supplier relations and management
Medical device QMS requirements
The main medical device quality management requirements can be summarized as given in the following subsections:
• Document Control
• Training Management
• Audit Management
• CAPA Management
Document control
Your medical device quality management system should include protocols and procedures for managing the many different documents that move within your organization, amongst sponsors, investors, and regulatory agencies throughout the lifecycle of your product.
This entire process is referred to as document control.
Nowadays, many manufacturers have switched from traditional paper-based QMS systems to automated medical device quality management software solutions with robust document control capabilities. Such software automatically collects data, routes documents for review and approval processes of various documents, and stores them in a single storage location.
Training management
International regulations/standards such as the FDA’s 21 CFR 820 and ISO 13485:2016 require you to only have specifically trained and skilled employees doing their job.
This means that all training procedures must be constantly evaluated, and all employee training records must be properly maintained.
Audit management
Both the FDA’s 21 CFR 820 and ISO 13485:2016 require medical device manufacturers to establish a proper audit process and to conduct regular quality audits.
This is to ensure that the medical device quality management system as a whole is compliant.
CAPA management
Under international regulatory rules such as the FDA’s 21 CFR 820 and the EU’s ISO 13485:2016, all manufacturers of medical devices must implement corrective actions and preventive actions (namely CAPAs) to rectify any instances of deviations or non-conformances that are likely to impact the quality of your product.
