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 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

design-medical-device-sharp

September 11, 2020

Keys to Success in the Digital Health/Mobile Medical Device Market: Experienced Partners

Digital health, including mobile medical devices and applications, is offering patients, providers, health systems, and insurance carriers’ real-world opportunities to improve medical outcomes and enhance the efficiency of healthcare around the world....
Read More >

April 30, 2020

Device Manufacturers Face Challenges to Balance Opportunity and Risk

With an increased focus on technology advancement and product development, medical device manufacturers are beginning to improve their devices and seize new opportunities. However, this comes with an...
Read More >
Potential Coronavirus Treatment

April 29, 2020

Sterling Medical Devices Partners with Cedars-Sinai and Aytu BioScience on Potential Coronavirus Treatment

MOONACHIE, NJ, April 29, 2020 — Sterling Medical Devices, a leader in custom electro-mechanical and software solutions for the medical device industry, announced today their partnership with...
Read More >

Need help with your medical device?

Let Sterling Medical Devices show how to bring your idea from concept to prototype to
FDA/CE approval with a free custom project analysis.
Request Free Analysis