Design and Development Files for Connected Medical Devices

Inside this White Paper

In today’s rapidly evolving healthcare landscape, connected medical devices—those that transmit, receive, or act on data—represent some of the most innovative yet complex tools entering the market. These products, often falling under FDA’s definition of interoperable devices, include technologies like insulin pumps, on-body glucose monitors, and other networked therapeutic or diagnostic systems.

Unlike simpler Class I devices, connected medical devices typically fall under Class II or III classifications, demanding rigorous design controls, documentation, and risk management. Because of this, manufacturers need to think beyond function and features. These devices require detailed planning for software interoperability, hardware integration, user interface validation, cybersecurity protocols, and strict adherence to regulatory requirements from the outset.

This whitepaper outlines the product realization process for connected medical devices, including the critical role of the Design and Development (D&D) File. If you’re a startup developing a prototype or an established manufacturer expanding your device portfolio, what follows is a roadmap to building compliant, submission-ready, and scalable devices.