The goal of any medical device is to improve the lives of its users. But what happens if a product doesn’t work as it should? What if a device breaks down or harms the patient? How can we ensure that the devices used in medical care work properly and are safe to use?
The need for a quality management system (QMS) in the manufacture of medical equipment is a must. When medical devices are manufactured, all devices must be inspected using thorough and appropriate procedures as part of a medical device quality control system.
Let’s take a closer look at what medical device quality control means, why it’s important, and how to better evaluate your quality control process for medical device manufacturing.

How is the quality control process of medical equipment?

Medical device quality By definition, the medical device quality control process is both reactive and product focused. In manufacturing, these processes (quality control) occur during and after production, as well as before shipping to end users. The quality control process tests individual products or a batch of products to verify that they meet product expectations and are free of defects.
In medical device manufacturing, quality control teams use various methods and criteria to root out non-conforming products. The three main areas of focus for any quality control process are:

1. Acceptance criteria: Quality control staff are required by the FDA to establish a formal document on how to determine whether products meet product specifications. Quality control staff are also responsible for documenting acceptance and tracking which products or batches meet these criteria and which do not.
2. Product testing: Quality control staff are expected to inspect, test and verify whether the product is ready for shipment. According to the FDA’s quality system regulations, medical device manufacturers are free to design their own quality control tests, but the FDA requires detailed documentation that proves the effectiveness of this verification.

3. Corrective and Preventive Action Management (CAPA): These investigative events are initiated when quality control personnel find a nonconforming product, perform a root cause analysis, and discover a system defect that led to the nonconformance.

Who is involved in the quality control process?

ISO 9001 defines quality control as: “The part of quality management that focuses on the fulfillment of quality requirements.” The international standard further identifies the key areas required for quality control processes, one of which is competence; This includes things like knowledge, skills, experience and qualifications of employees.
The primary role of quality control is inspection, such as checking devices for cracks or broken parts. However, medical devices such as medical extruders are often complex. Ensuring that these products are not defective requires a team of trained, competent and diligent inspectors equipped with the extensive knowledge dictated by the above acceptance criteria document.

Quality control of medical equipment VS quality assurance

An important distinction to make is the difference between quality control and quality assurance. Although both are part of the same quality management system, their roles and responsibilities could not be more different. Quality assurance prevents defects in the manufacturing process of a medical device. Quality assurance occurs during the manufacturing process of medical devices. Quality staff look for problems in processes that may lead to nonconforming products to fix.

However, for quality control of medical devices, the main area of ​​concern is the “product” rather than the process. Quality control testing does not begin until a batch or lot of medical devices is ready for shipment, at which time this specialized team is responsible for the final inspection and review of the batch or lot to ensure the devices are ready for sale.

Why do you need a quality control process?

The number one reason your medical device company needs quality control processes is because the health and safety of patients depends on it. When medical devices fail, the results can be catastrophic. While such occurrences are extremely rare, the worst-case scenarios that can occur soon without a proper quality control process in place include:

• An implantable insulin pump cannot administer the correct glucose level, putting patients at risk of diabetic shock
• Spinal surgery instruments have chemical leaks that can cause paralysis.
• A defibrillator with a broken electrical component renders it unable to deliver a life-saving charge.

These are all real-life examples of medical devices that have been registered due to poor quality control processes. However, even beyond the importance of protecting users, there are business-level needs for the quality control process.
One important area is the regulatory requirements needed to market a device. As stated in the international standard ISO 13485:2016, quality control of medical devices is a vital part of any quality management system. Quality management systems are universally required by regulatory bodies, including the FDA and under the EU medical device regulations.

Another reason for quality control processes is the sheer financial impact that poor quality has on medical device companies. A McKinsey study found that poor quality medical devices cost the medical device industry $26 billion to $36 billion annually. This occurs both directly, such as troubleshooting, and indirectly through material loss or time-to-market delays.

How to evaluate your quality control process?

Regardless of size or age, every medical device company needs to think carefully about how to approach quality. This type of quality planning can be done in a number of ways, such as high-level ideas about quality management or creating an actual quality system.
However, quality control activities are often more tangible, such as on-site inspections of physical products. So, what exactly should you look for when evaluating your medical device company’s quality control process?

Create a quality management program

ISO 13485 specifically requires the development of a quality management program, a document that defines “quality procedures, resources and activities related to the devices that are designed and manufactured.”
Doing so helps clarify what is being tested by quality control, how the role of quality control fits into the overall QMS, and the responsibilities required of each team member and department.
Collaborate with product developers for quality control insights
By creating the same collaborative spirit, quality control processes can be greatly improved by discussing device features with the design team. Fewer than your engineers understand the inner workings of a product, and they can shed light on device inputs as well as uncover any gaps in your quality control tests.

Write descriptive acceptance criteria?

The quality control process is all about establishing strong acceptance criteria. This document contains the exact specifications for a device that must be considered fit for sale, so it’s important to evaluate the language used to define the features your quality control team will test.
Requirements should be written clearly and unambiguously. However, they should also avoid information overload, which could potentially cause testers to unnecessarily flag a product as non-compliant.

Create complete documentation

As with any part of the medical device lifecycle, documentation is essential to the quality control process. This is reflected in regulatory requirements such as FDA’s 21 CFR Part 11 – which expressly requires documentation of quality control testing.
It is also important to record the inevitable changes that occur during the device’s life cycle. Make sure you use a tracking matrix to track all changes to the design, inputs, outputs, and user requirements.

Changes to your traceability may affect your acceptance criteria. Keep records of all acceptance criteria updates and be sure to train quality control staff on new processes.