Streamlining FDA Approval for Remote Health Monitoring Devices
Overview
Digital Health Solutions was engaged by a Boston-based client company for the development and FDA approval for two generations of wearable medical devices . These wearable systems, designed for remote continuous multi-parameter vital signs monitoring from home, required comprehensive engineering, regulatory, and software support to bring them to market. Our responsibilities spanned from engineering development (hardware, firmware, cloud), Design History Folder development, Human Factors, Cybersecurity, Risk Management, Verification and Validation, to final FDA approval, utilizing our expertise in medical device compliance and late-stage product enhancements.
Project Highlights
Fast-track FDA clearance: The client aimed to secure 510(k) clearance for two generations of Class II devices with limited internal knowledge of regulatory processes.
Finalize critical software and ensure compliance: Firmware and cloud systems required completion and validation to meet IEC 62304 and FDA cybersecurity guidance.
Close quality and documentation gaps: The team needed to complete comprehensive documentation and validation reports for FDA submission under time pressure.
Challenge
Regulatory Compliance Support: Led DHF gap analysis, created compliant documentation, and managed FDA submission and review, including deficiency responses.
Systems, software, and cybersecurity development: Finalized software, revised electronics, and implemented wireless systems with secure data handling and BLE optimization.
V&V Testing, cybersecurity, and usability validation: Delivered full V&V per IEC and ISO standards and led human factors studies to meet FDA expectations.
Our Approach
Fast-track FDA clearance: The client aimed to secure 510(k) clearance for two generations of Class II devices with limited internal knowledge of regulatory processes.
Finalize critical software and ensure compliance: Firmware and cloud systems required completion and validation to meet IEC 62304 and FDA cybersecurity guidance.
Close quality and documentation gaps: The team needed to complete comprehensive documentation and validation reports for FDA submission under time pressure.
Impact
Two devices, two clearances: Achieved FDA approval for both generations, expanding functionality from vital signs to SpO₂ and temperature.
End-to-end execution: Delivered complete engineering, documentation, and regulatory support to meet FDA standards.
On-time market launch: Enabled rapid submission, clearance, and manufacturing despite client’s limited FDA experience.