To manage the quality of medical devices, we must first build an end-to-end product quality system

As an important modern medical tool, medical devices are special products related to people’s life and health. The quality of medical devices has become one of the important guarantees of medical devices, so the country is very strict in the quality management of medical devices. In addition to the various specifications issued before, many new regulations have been issued in recent years, which put forward higher, stricter and more standardized requirements for the quality management of medical devices. However, according to the relevant inspection data of medical device quality management in China in recent years, there are still many problems in medical device quality management, mainly related to the business quality, personnel level, operation management, hardware and software facilities. So, in the face of increasingly strict supervision, our medical device enterprises, whether they are production-oriented medical device production quality management or circulation-oriented medical device operation quality management, how to control the quality and prevent non-conforming products from entering the market, not only face high fines, but also endanger people’s life safety.  

How can we help our medical device enterprises to achieve medical device quality management compliance and product quality without worries? In this issue, we will work with digital medical device quality management experts to bring you some countermeasures for medical device quality management.  

Medical device quality management cannot be generalized

Throughout the medical device industry chain, a complete industrial chain is formed from production enterprises, circulation enterprises, medical institutions and patients. There are different types of enterprises in the industrial chain, and different types of enterprises have different quality management standards and procedures for medical devices. Let’s take an example: a typical example is a production-oriented and circulation-oriented medical device enterprise. As shown in the figure below, NMPA classifies medical devices into three levels according to their safety, which are supervised and managed by three levels of government departments.  

Different categories: medical device operation quality management, medical device production quality management, and different safety levels determine the particularity of medical device quality management. For example, the third category is implanted into the human body to support and maintain life, so the control of its safety and effectiveness is far more strict than the first and second categories. Therefore, when we talk about the quality management of medical devices, we should never generalize.  

The quality management of medical devices should be clearly classified first

Based on the above, we may take the first two types of medical device quality management in the industrial chain as an example. Production-oriented medical device enterprises mainly strictly control the quality management of medical device production; However, circulation medical device enterprises need to strictly control the quality management of medical device operation. In this regard, different types of enterprises in medical device quality management are based on different specifications and quality management systems. We take business and production norms as an example:

Code for Quality Management of Medical Device Operation (implemented on December 12, 2014)

The Code for Quality Management of Medical Device Business has nine chapters and sixty-six articles, requiring medical device business enterprises to establish and improve the quality management system in accordance with the Code, and take effective quality control measures in medical device procurement, acceptance, storage, sales, transportation, after-sales service and other links to ensure the quality and safety in the business process.  

Code for Quality Management of Medical Device Production (implemented from March 1, 2015)

There are eighty-four articles in thirteen chapters of the Medical Device Production Quality Management Specification, which requires the medical device manufacturer to follow the quality management system that is suitable for the medical device produced in accordance with the Specification and ensure its effective operation. The risk management shall be carried out throughout the whole process of design and development, production, sales and after-sales service, and the measures taken shall be consistent with the risks existing in the product.  

Leading medical device quality management paradigm

When we clarified the quality management of medical devices: different categories, different specifications, medical device quality managers began to seek the best solution at present. Different from the medical device quality management procedures many years ago, more and more medical device benchmarking enterprises now use digitalization to realize the quality management of medical device operation and production. We take the medical device operation quality management as an example:

The leading medical device operation quality management uses SAP cloud ERP system to realize effective medical device quality management by establishing a complete end-to-end product quality traceability system from purchase warehousing to sales outbound. In fact, the SAP cloud ERP platform behind them has already helped them build a standardized, simplified and unified information platform, integrate sales channels, enterprise operations and customer relationships, achieve efficient operation of enterprises, accelerate business development and transformation, and maintain industry advantages.  

It can be seen from this that in the digital era, no matter the quality management of medical device operation or the quality management of medical device production, there is no end to end product quality system: from the purchase of raw materials, the access of suppliers, the management requirements of product validity to certification qualification, to form a set of quality management value chain, etc. These requirements are basically difficult to achieve without the help of digital means.  

Above, we only understand the relevant contents of medical device quality management and medical device quality management procedures from a macro perspective, and we need to subdivide our enterprises into medical device operation quality management and medical device production quality management, so as to better understand the relevant provisions of medical device quality management, build an accurate medical device quality management system, and select medical device quality management systems and solutions. More specific solutions for medical device quality management can be found on the official website: medical device industry solutions, white paper on digital transformation of medical device enterprises.

This article "To manage the quality of medical devices, we must first build an end-to-end product quality system" by AcloudEAR. We focus on business applications such as cloud ERP.

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