Medical Device Verification
Smart, cost effective verification services for medical device companies
Done properly, medical device verification brings immense value to the medical device development process as it maximizes the success rate of FDA/CE Mark submissions. However, medical device verification can be a resource-intensive process, and poor planning and execution of verification activities can result in delays, unforeseen cost overruns, and even product recalls.
The terms verification and validation are often intermixed, but they are different. Verification asks the question, “Are you building it right?” To answer this question, medical device developers have to verify that specifications are implemented the right way. What’s more, they have to determine if both inputs and outputs are in compliance with regulations or standards, and then prove it.
Ideally, medical device companies start verification processes early in their medical device design planning phases and throughout their entire development lifecycle. However, many medical device companies come to us for verification services later in the medical device development process. Our experts can help you at any stage to demonstrate that all software requirements are implemented correctly and completely and are traceable to medical device system requirements.
Wherever you are in the development lifecycle, Sterling Medical Devices is your trusted partner for medical device verification. At Sterling Medical Devices, we give proper emphasis to medical device verification during the product design and development phases to help our clients build medical device products the right way the first time.
Independent medical device verification from a trusted partner
Sterling Medical Devices employs a team of full-time experts to conduct independent verification services of medical devices to support your submissions. During the verification process, we actively test software for consistency, completeness, and correctness and develop supporting documentation such as design history files (DHF).
Testing is an important part of verification to ensure software design outputs are aligned with software design inputs, but it’s just one of the methods we employ. Every step of the way, we help ensure that the functionality of your medical device meets stated requirements through the following verification activities:
• System Testing
• Unit Testing
• Integration Testing
• Code Reviews
• Regression Testing
• Verification Reporting
Learn more about our medical device verification services. Call 201.227.7569 ext.2