Medical devices can play critical roles in the lives of their users. Thus, it’s important to confirm that a given medical device is both effective and safe.
Testing such devices before making them available to the public is essential. However, it’s also vital to be confident the methods used to test a medical device are reliable. This is the foundation of test method validation, or TMV.
Understanding Test Method Validation
Test method validation can take several different forms. Generally, though, it involves analyzing test results to evaluate the overall quality and reliability of a given test method.
For example, perhaps one testing method for a particular medical device yields fairly similar results time and time again. In this instance, one might be able to confidently state that this testing method is valid, given the fact that it can reproduce the same results on a consistent basis. It might not be possible to say the same about another testing method.
Why Testing Method Validation is Critical
There are many reasons proper test method validation is a significant component of the overall medical device manufacturing process. Noteworthy examples of such reasons include (but may not necessarily be limited to) the following:
Federal law (specifically statute 21 CFR Part 820.72) requires that a certain degree of test method validation be part of the medical device manufacturing process before a medical device reaches the market. A company that fails to perform such testing may be in violation of the law.
Optimizing the effectiveness of a medical device is perhaps the most significant reason for a medical device manufacturer to perform test method validation. Again, patients rely on these devices to perform a range of tasks to keep them healthy. They need to know they can trust their medical devices will work as intended.
To some extent, proper test method validation could also theoretically help medical device manufacturers identify hazardous conditions or defects that might put customers at risk. Although this isn’t necessarily common, identifying safety risks and addressing them properly is another benefit of thorough test method validation.
Improving Future Testing
Test method validation can tell a medical device manufacturer whether a testing method delivers quality data. It may also tell them whether that testing method is worth applying to future medical devices.
By performing careful and thorough medical device testing every time a new device is being prepared for the market, manufacturers can gradually make significant improvements to their overall approach to testing their products.
Manufacturing Effective Medical Devices is Essential
It’s worth remembering that test method validation is still just one component of manufacturing medical devices. It’s important that the companies designing these products coordinate with reputable manufacturers. When every aspect of the manufacturing process is optimized, these products are much more likely to prove useful and safe.
Learn More About Medical Device Manufacturing Options
At Coastline International, Inc., offering medical device manufacturing solutions to our clients, we’d be happy to answer any questions you may have about our approach to test method validation. Contact us online or call us at 888-748-7177 for more information.