Medical Device Verification and Validation

two men using computers

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 1100 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.

Resources

Hands compare spinal x-rays

January 15, 2021

Three Takeaways from the Human Factors Engineering & Usability Studies Congress

In early December, I had the good fortune of attending the Human Factors Engineering & Usability Studies Congress online. Although the event could not be held in person, for obvious reasons, it...
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Sterling Medical Devices's Dan Sterling speaking

December 17, 2020

Here in New Jersey, Sterling Medical Devices Makes Med Tech to Order

Dan Sterling of Sterling Medical Devices | Screenshot by Esther Surden Suppose you are developing an implant that involves both hardware and software, or an external device for diagnosing a...
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healight

November 5, 2020

Healight: The Moonshot Not Yet Heard Round the World

Imagine a technology so innovative and groundbreaking in its potential impact that its sponsor is calling it “a moonshot” and “an opportunity so big you could build an entire company around...
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