A medical device company asked Elexes to prepare a regulatory strategy for an active device. The goal was to bring their product into the US and European markets by complying with all applicable regulations, and by performing all the necessary testing.

Active Medical Devices like cochlear implants, cardiac pacemakers, bladder stimulators, and diaphragm stimulators are subject to rigorous regulatory and testing requirements. A thought-out regulatory strategy helps device companies in selecting the right path for bringing their product to the market in a timely and cost-effective manner. The regulatory process that Elexes suggested, helped the client in bringing their product to the market in one go, instead of going back and forth with regulatory bodies.

Elexes successfully planned a market-specifc stratergy for the client. We advised the client to comply with 90/385/EEC, prepare a design dossier, select the right notified body (that specializes in active devices), and select a European authorized representative, who has experience with the selected notified body and active implants, for the European market. For the US market, we advised them to do a pre-submission, since there was no existing Predicate. We asked them to put the new technology in front of the FDA, and get FDA’s input on the proposed testing, types of submission (510k, PMA, etc.), and data. Since the technology had the potential to address an unmet medical need and serve an under-served patient population suffering from life-threatening or irreversibly debilitating diseases or conditions, we helped them explore the option of Expedited Access program (EAP).

The strategy formulated by Elexes for European and US markets, helped the device manufacturer in selecting the correct partners, initiating an early dialogue with the regulatory bodies, executing the right testing and in the end, successfully complying with the right requirements and standards. This saved the manufacturer a significant amount of time and money.