Our capabilities span a breadth of experience from working with Leading Medical Device Corporations to Start Ups leading to the deep experience in the medical device industry that it takes to innovate and bring your products through the CE and FDA regulatory submissions processes to the market.

Working with your team to iterate existing medical devices or develop new medical products Advantage uses a full life cycle approach to medical device engineering which minimizes the development time and speeds your time to market. We focus first on completely understanding your development needs, addressing regulatory, engineering and clinical constraints to ensure that the overall project requirements are met.

With a proven track record of FDA and CE Mark approvals 510K, Pre Market Approvals (PMA), for Class I and II devices, employing the verification/validation of medical systems as needed to support submissions results in successes for our clients.

Take advantage of our industry expertise in engineering your medical device hardware and mobile device applications.