What you need to know about medical device validation
When medical devices work properly, they keep us healthy, moving, monitored, and—in some cases—alive. They're a growing sector in the healthcare industry and an essential part of modern life for many. To ensure medical devices are safe and effective for patients and consumers, the US FDA (Food and Drug Administration) imposes regulatory requirements on their development, production, and sale. One way the FDA does this is by requiring that companies who make medical devices validate their products before they can be sold. Medical device validation is a process of demonstrating that a device meets all relevant safety and performance standards set by the FDA.
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As a quality or regulatory professional in the industry, the onus is usually on you, and ultimately your employer, to ensure the medical devices your company markets are compliant to their relevant regulations. An article published by the Regulatory Affairs Professional Society (RAPS) on device validation confirmed that although numerous departments are involved, most companies appoint someone in quality to lead the validation process, as they are knowledgeable in the regulations and should help to keep the process objective.
Because medical devices vary greatly between their intended uses and purposes, and their levels of risk, there isn't a standard checklist to fill out and prove regulatory compliance throughout the manufacturing process—we all wish it were that easy. The FDA mandates medical devices must meet design verification and validation, and you have control on how to achieve this requirement. Per CFR (Code of Federal Regulations) Title 21, Part 820, FDA design validation means establishing, by objective evidence, that the device meets user needs and intended use.
Verification vs. validation
The terms verification and validation are not interchangeable and are sometimes confused in the industry. They're both part of the medical device product development lifecycle, but each are very different, yet equally important to the manufacturing process. As described above, validation is objectively proving the device meets user needs by working as it should in the real world. While, the Code of Federal Regulations Title 21, Part 820, defines verification as confirming by examination that the device meets the specified product requirements.
To explain further, verification is comparing the device at each step of the development against the established design specifications. Basically, do the design outputs, meet the design inputs? Verification of the device should be the logical first step, as there would be no need to test validation, if the product does not meet fundamental product specifications.
To put it in simpler terms, medical device design verification is determining if you built the product right, while medical device validation determines whether the right device was built.
Why is medical device validation important?
The ultimate purpose of medical device validation is to determine whether you built the right product for its desired intended use. Even if you meet device verification with your design outputs complying with design inputs, it doesn't matter if the product doesn’t work as intended. If you don’t build the right product, it could be a matter of life and death, especially when you're developing high risk medical devices like pacemakers, vascular stents or mechanical ventilators. Thus, as necessary as it is to validate all medical devices, it's critical to validate high risk devices that carry the threat of injury or death if they were to malfunction.
If that isn’t reason enough, RAPS confirms one of the most common issues leading to warning letters from FDA is inadequate process validation. In order to keep the product on the market and safe for use, validation needs to be understood by those involved at your company, and put in place by the quality and/or regulatory team. Device validation is key to identifying risks and ensuring product quality.
Steps for medical device validation
As noted above, while a medical device manufacturer must ensure device validation, they do have latitude on how to achieve this goal. There are so many different types of medical devices manufactured and marketed here in the US, the regulation cannot describe in detail how to produce and/or validate a device. But once design verification has been confirmed, there are basic steps required for validation to meet FDA GMP (Good Manufacturing Practices) as described in 820.30 (g) Design Validation:
- Each manufacturer shall establish and maintain procedures for validating the device design.
- Design validation shall be performed under defined operating conditions on initial production units, lots, or batches, or their equivalents.
- Design validation shall ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions.
- Design validation shall include software validation and risk analysis, where appropriate. · The results of the design validation, including identification of the design, method(s), the date, and the individual(s) performing the validation, shall be documented in the Design History File.
Again, this is just the framework, and validation is definitely not as spelled out, or as easy to understand, as verifying a device. This is why the first and most important step for your company is to have trained personnel on the validation team that ensure an actual validation plan is in place to meet the compliance needs for each device produced at your company.
Tips for medical device validation
As with most FDA regulatory guidance, the mandates are specific, but the steps to get there are not, which gives manufacturers flexibility when it comes to determining compliance. This is beneficial to manufacturers, otherwise we would have to follow the same process, whether we were making low risk tongue depressors or high risk devices.
If the core steps above include fundamentals of planning, reviewing, relevant validation testing methods and documentation, you can ensure a more effective and efficient process to completing your compliance goals. And this can ultimately help your company get the product to market faster.
820.30 (g) Design Validation outlines tips for making medical device validation more effective and efficient:
The establishment of a validation plan should begin early in the design process. The performance characteristics should be identified and validation methods and acceptance criteria established to ensure the product will meet the end user’s needs and intended uses are addressed.
Do this early and often, as a review may expose deficiencies in the original intended uses and user’s needs. Validation review also allows the manufacturer to modify the validation plan as necessary.
You may find it surprising that many medical devices do not require clinical trials, however they all require a clinical evaluation, at minimum. This evaluation would require some real-world testing or simulated use. (Real World testing is ideal, if possible.) Ensure the validation includes the product packaging and labeling as the end user would receive, as these factors may affect the product performance. Validation methods should be well documented and include proper identification of the devices, methods used, date of validation, and personnel involved.
The saying applies, if it is not documented, it is not done. This is really the most important step of the entire process to prove the validation was done, and that the medical device is safe and effective for use. If the product does not comply, the notes will also be beneficial on what needs to happen to pass compliance. The Validation is a compilation of the results of all validation activities.
Validation is vital
Ready to streamline your process for new product development? Start by putting your device validation team in place and ensure they have the appropriate training and up to date on the latest guidance and industry trends on medical device validation methods. Medical device validation is vital to patient safety and should never be taken lightly. With a well-trained team in place, you can ensure compliance while also getting your product to market faster.