How Quality Assurance and Quality Control is Different for Medical Devices vs. Pharmaceuticals

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If you’re considering a career in pharmaceutical quality assurance and quality control in the medical device industry, now is a great time to pursue training. The medical device industry is booming, with the global market for medical devices expected to grow to $409.5 billion by 2023.

Medical devices, which can range from simple devices like disposable gloves to advanced technology like pacemakers, must, like pharmaceutical drugs, be approved by Health Canada before they can be sold and marketed in Canada. If you choose to study pharmaceutical quality assurance and quality control, you will learn about the measures that apply to medical devices and how they differ from pharmaceuticals. Let’s look at just a few of those differences below.

Medical Devices Are Classified Differently From Pharmaceuticals

Medical devices are classified under the Food and Drugs Act into one of four classes, ranging from Class I to IV. Classification is based solely on risk. Class I devices, like surgical instruments, pose the lowest risk, while Class IV devices, like pacemakers, pose the highest risk. The higher the class a device is categorized in, the more stringent regulations it is subjected to.

Medical devices that pose the highest risk—like pacemakers—are given a Class IV rating

Medical devices that pose the highest risk—like pacemakers—are given a Class IV rating

Drugs are also classified into four categories: Schedule I to III and Unscheduled. However, these categories differ from medical device categories in a number of ways. For one, drug classification is only assigned to a drug after that drug has been approved for sale by Health Canada. Medical device classification, on the other hand, is determined much earlier in the approval process.

Furthermore, drug classification is based not only on risk, but also on medical use. A drug’s risk—at least for determining its classification—is largely based on its potential for abuse or dependency. For medical devices, risk is determined by a larger set of factors, including what the consequences of a device malfunction would be, how invasive it is, and the duration of contact the device has with patients.

Regulation of Medical Devices Differs Substantially from Pharmaceutical Testing

As professionals working in quality assurance and quality control know, testing of therapeutic products like drugs and medical devices is extensive. However, the testing process for medical devices is not the same as pharmaceutical testing. Whereas new drugs must undergo phased clinical trials (designated Phase I to IV), there is no such phased testing for medical devices.

However, manufacturers must still submit an Investigational Testing Application (ITA) for Class II to IV devices to Health Canada. An ITA gives a device manufacturer or sponsor authorization from Health Canada to conduct a clinical study or other form of investigational testing to determine the safety and performance of the device. Approval of an ITA is important. Because there are so many different types of medical devices, the testing process for each depends on what its intended use is. The results of testing are later submitted to Health Canada to help determine whether the device will be approved for sale.

Cybersecurity for Medical Devices Is a Unique and Developing Issue in Quality Assurance and Quality Control

Some medical devices present potential cybersecurity concerns, which is an issue that does not affect pharmaceuticals to the same extent. Devices like pacemakers, defibrillators, operating room monitors and insulin pumps are now being made that collect data about patients’ health. While this data can be used to improve treatment, it also could be exposed by a security breach. Some devices may even be tampered with through hacking.

Medical device cybersecurity is a developing area of quality assurance and quality control

Medical device cybersecurity is a developing area of quality assurance and quality control

Regulators are currently trying to come up with ways of addressing this unique risk faced by medical devices. Health Canada, for example, released draft guidance last month aimed at providing medical device manufacturers advice on measures for improving cybersecurity. The document is currently open for a 60-day comment period and it is not considered law, so it’s too early to say what Health Canada’s final recommendations for improving cybersecurity for medical devices will be. If you want to study pharmaceutical quality control, you may get to see how these developments in medical device cybersecurity regulations develop over time as the industry continues to grow and innovate.

Are you interested in an exciting career in the pharmaceutical industry?

Contact AAPS College to learn more about our pharmaceutical quality control courses.