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Medical Device Verification and Validation

It is imperative to know how to properly perform medical device verification and validation. If you test your device too frequently and inefficiently this could be very costly, but if you wait too long in your device’s life-cycle or do not test the proper things, this could require that you redesign your device. Redesigning your device can be costly, painful, and will delay your device getting FDA/CE approval. For that reason, early medical device verification and validation testing can help reduce risk and make sure the device is efficient and safe to use by allowing engineers to find bugs and vulnerabilities.

At Sterling, we strongly believe that well-written documents and proven medical device engineers are essential to smooth testing of your device. With the experience of over 1,400 projects, we have seen virtually every possible configuration, so you can rest assured that your project is in expert hands. Through the use of verification activities in software testing – including test protocol development and testing for 510(k) submissions, to risk management and hazard analysis – our medical device testing team can help you navigate the complex regulatory processes. Our wide range of medical device verification and validation services for Class I, II, and III devices are carried out by our dedicated team of medical device testing experts. We meet your requirements and make sure that every aspect of your medical device product – software, hardware, and electrical components – is properly tested.

Medical Device Verification and Validation throughout the Development Process

Medical device companies must ensure the safety of patients and device users. Thus, comprehensive testing should be conducted throughout the development process. Our medical device verification and validation services are developed in a way to ensure that the device works as it should in the field. Our engineers will work with you to help define requirements early in the process to uncover hidden details and issues as early as possible. We combine our extensive medical device industry background and our world-class technical capabilities to help you achieve your goals – from submissions to market release.


FDA medical device regulations graphs.

April 4, 2022

FDA Medical Device Regulation Guidance for 2022

In the United States, the U.S. FDA (Food and Drug Administration) provides medical device regulation through the CDRH (Center for Devices and Radiological Health). The agency recently released...
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February 18, 2021

5 Mistakes Medical Device Startups Make

Startups are the lifeblood of medical device innovation. Without universities researching ways to solve pressing healthcare problems or doctors with experience in a particular field who have an idea to develop a prototype medical device that could help patients, the future technologies needed to help save lives wouldn't happen. But the long, arduous road through the FDA submission process to get market approval can take a long time and cost a lot of money without help. Sterling Medical Devices has been helping startups through the FDA approval process since 1998 without ever having a submission rejected.
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September 8, 2020

Breathing Pacemaker

Sterling Medical Devices performed design services for a Class III breathing pacemaker with Major Level of Concern software, intended for use by patients who have lost neurological control of respiration. This life-sustaining device is comprised of two main components: an internal passive receiver and an external controller....
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