Medical Device Quality Management System (QMS) – A Brief Description

The quality management system (QMS) for a medical device consists of a series of processes and procedures for designing, manufacturing, supplier management, product labeling, storage and distribution, clinical data, risk management, complaint handling, and more. Some type of QMS is required for most medical devices, which varies in complexity depending on the class the device belongs to. For example, manufacturers of Class II (medium-risk) or Class III (high-risk) devices will need to adhere to a different QMS implementation than those producing Class I devices such as non-reusable surgical instrument devices. Hence, it is important to find out the class your device belongs to before going for a QMS.

International Regulations for Medical Device QMS

It is mandatory to implement and maintain a quality management system as part of product registration in every major market. In the US, device manufacturers are required to comply with the  FDA’s Quality System Regulation 21 CFR Part 820 while the European manufacturers are required to provide evidence that they have fulfilled the requirements of ISO 13485.

The difference between ISO 13485 and 21 CFR Part 820

The ISO 13485 is an international quality management system standard in the medical devices sector followed by companies selling their products in Europe, Australia, Canada, and other markets. Any organization that designs, develops, produces, installs, or provides technical assistance for medical devices or services connected to them can use this standard. Other than Canada, ISO 13485 is a de facto for companies which mean most companies comply with the ISO 13485 requirements as per the national medical device regulations.

For a medical device company operating in the US market, 21 CFR Part 820 is FDA’s Quality System Regulation (QSR), which preceded the original publication of ISO 13485, and is the set of policies and procedures intended to ensure that all medical devices created and developed within the US market are safe at all stages of development. US Manufacturers who intend to distribute their products globally are required to meet both the ISO 13485 standard as well as 21 CFR Part 820. Similarly, all medical device manufacturers from countries outside the US that plan to distribute their products in the US market need to comply with the US FDA 21 CFR Part 820. The quality management system in countries such as Brazil and Japan are very similar to ISO 13485, though having slightly different requirements. As a result, manufacturers can have a single QMS that complies with the QMS requirements of the US, Canada, Europe as well. Despite being a daunting task, in the long run, it is well worth the effort to integrate disparate quality management systems into one integrated system.

In an effort to modernize and harmonize its QSR (21 CFR Part 820) for medical devices with internationally recognized Quality Management System (QMS) set by the International Organization for Standardization, ISO 13485:2016 Medical devices, which is used by many other regulatory authorities, FDA  published a proposed regulation, requesting public comment. If finalized, this action would bring in harmony the QMS requirements for FDA-regulated devices with other regulatory authorities.

Medical device consulting companies that get to market first with a viable product are the winners in the industry, and what easier way than using QMS certification services of a professional body to assist in your endeavor and protect your quality systems that can meet the toughest regulatory inspection.