Medical Device Validation
Validation services from a trusted medical device development partner
According to FDA 21 CFR part 820, medical device validation is required for successful FDA submissions. This makes validating your medical device product an essential part of the medical device development process. However, validation oftentimes is an afterthought because it typically happens near the end of the design or redesign of a medical device. The reality is that you need to build a validation case early in the medical device development lifecycle, or else you put your product at risk of getting audited, or worse, recalled by regulators.
Sterling Medical Devices can help wherever you are in the development lifecycle. We can provide independent review of your device to support your FDA/CE Mark submission. This is especially vital for companies who may only have a limited number of personnel and are not able to provide the necessary level of independent review.
Our medical device validation services include, but are not limited to:
- Safety testing
- Unit module testing
- White Box testing
- Black Box testing
- Protocol execution and reports
- Automated testing
- GMP process validation (IQ/OQ/PQ)
- Usability and human factors review
The medical device validation process
Through evidence-based confirmation, medical device validation answers the question, “Are we building the right product?” According to the FDA, medical device software validation is “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.” What this means is that you must know the intended use of your medical device product: this is the pre-requisite to an effective medical device validation effort. Here at Sterling we can help you with both. We can help you identify all intended possible uses as well as perform a complete validation undertaking on your device.
Regulating agencies in the medical device industry expect a high-level degree of validation activities to be performed during the medical device development process. During the medical device validation process, a medical device is thoroughly tested against every product and engineering requirement. Typical validation activities occurring throughout the medical device development process and at the end of the software development life cycle can vary depending on the risk-level of your device (Class A, B, or C). Tracking the data with painstaking detail and filing the documentation is optimally important because an FDA regulator expects to see demonstrable evidence that all reasonable tests were performed.
Your trusted partner for medical device validation
When it comes to validating your medical device product, it is important to rely on an experienced partner who can independently guide you throughout the medical device validation 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 to help you ensure a successful FDA/CE mark submission.
As your partner, Sterling Medical Devices brings value to the medical device development process. We give proper emphasis to medical device validation throughout the development lifecycle to help our clients build medical device products the right way the first time.
Learn more about our medical device validation services. Call 201.227.7569 ext.2