Medical devices can be lifesavers, both for immediate issues (such as defibrillators for heart attacks) and long-term care (such as pacemakers).
However, without adequate testing, medical devices will deliver subpar or even detrimental care to patients. The U.S. Food and Drug Administration (FDA) requires medical device manufacturers to perform an extensive range of testing for new devices before they can be marketed and sold.
This article discusses some of the medical device testing standards that manufacturers must observe for basic safety and essential performance.
Medical device testing is an ongoing process that starts with the initial design and extends throughout the product lifecycle.
Medical Device Classifications
Because the testing requirements vary according to the type of medical device, it’s helpful to understand medical device classifications. The FDA recognizes three classes of medical devices:
- Class I: Simple, low-risk devices such as tongue depressors and cotton swabs
- Class II: Medium-risk devices whose failure would not cause immediate harm or death to a patient, such as diagnostic test kits
- Class II: High-risk devices whose failure could cause immediate harm or death, such as ventilators
Because the testing requirements for Class II and III devices are more stringent, medical device testing standards for these devices are the focus of this article.
Design Verification and Validation
During the medical device design phase, manufacturers define the scope of the device’s capabilities and intended uses. According to the FDA’s guidelines for “current good manufacturing practices” (cGMP), the device definition should have two levels:
- Product requirements, which define what medical condition or indication the device is intended to address
- Design specifications, which are a detailed list of device features and how they are supposed to work
Every item in the design specification must be mapped to one or more product requirements, and vice versa. This two-way traceability ensures that every product requirement is addressed and every specification supports at least one product requirement.
The design testing process likewise has two levels: verification and validation.
- Verification testing is intended to show that each item in the design specification has been met.
- Validation testing shows that each of the product requirements is satisfied.
Verification and validation are conducted by the manufacturer’s developers and testers. Once this testing is completed and documented, the device can move on to clinical trials.
In the U.S., the requirements for clinical trials vary by device classification and whether the device is similar to devices already on the market.
- Class III devices and Class II devices that are not like anything else on the market must go through extensive (and expensive) clinical trials as part of the FDA’s Premarket Authorization (PMA) process.
- Class II devices that are substantially similar to existing devices on the market go through the less-stringent Premarket Notification (PMN) process, documented in an application known as a “510(k) submission.”
Device clinical trials are conducted by third-party organizations such as hospitals and medical schools. In these trials, the device is tested with actual patients to determine that it is safe and effective for its intended use.
The FDA reviews the results of the clinical trials and either approves or denies authorization to market and sell the product in the U.S.
Manufacturing Quality Assurance
The best-designed medical device is worthless if its maker has shoddy manufacturing practices that result in poor quality.
Thus, every medical device manufacturer must implement a quality system and instil a culture of quality among its employees. In the U.S., medical device manufacturers must design their quality systems according to the medical device regulations of Title 21, Part 820 of the Code of Federal Regulations (21 CFR 820).
According to the guidance documents for 21 CFR 820, a major part of the quality assurance system is quality control of the manufactured devices. The level of scrutiny and testing is related to risk.
For higher-risk devices, such as implantable pacemakers and artificial joints, every single device might be tested to ensure that it is working properly and has no manufacturing defects. For lower-risk devices, or those (such as blood testing kits) that can’t be tested without consuming them, the manufacturer will use a sampling test method for each production run.
Other regulatory requirements and industry testing standards may also apply, such as the iec 60601-1 and iec 60601-1-2 standards for medical electrical devices, and standards related to sterility assurance. Regardless of the standard or level of testing, the manufacturer must keep records of the testing that can be audited by FDA inspectors.
Industry-Leading Support Medical Device Testing
Testing is the only way to show that your medical device has a robust design and is manufactured with high quality. As the leader in full-service medical device design, development, manufacturing, and test services, RBC Medical knows testing inside and out.
We can provide testing solutions, product testing, and support through a 510(k) review for your medical device product. Contact us today to learn how we can be your medical device testing partner.