Client: Late-stage startup leveraging AI/ML in the Dementia Diagnostics space
Challenge
The client had previously submitted a 510(k) to the FDA and had received a deficiency letter. The deficiencies were primaritly cybersecurity issues, among other less significant issues. The client had a short runway to remediate, resubmit and secure market clearance, to stay on track for commercial milestones.
Additionally, the client’s Quality Management System (QMS) was primarily focused on physical hardware device development, and so the client also needed support with improving their software development processes and procedures.
The client was also unsure about their regulatory strategy and were keen to hear our advice.
Approach
The BlueBridge Technologies (BBT) team ramped up by reviewing the FDA feedback, gaining access to a demo system and leading workshops with key client stakeholders. In tandem, BBT applied a Systems Engineering approach, and quickly generated a high-level model of the system in System Modelling Language (SysML). Replaying & adjusting this model with the client was very effective in aiding alignment.
BBT led the Security Threat Model & Boundary Analysis work and subsequent identification of Risk Control Measures (RCMs). This necessitated code and configuration changes, a new release and associated verification.
BBT partnered with the client on updating their Design History File (DHF) to reflect the extensive CyberSecurity analysis and new release.
BBT provided extensive guidance and support to bring the client’s QMS into compliance with IEC 62304, and BBT provided advice on the most efficient and effective software development lifecycle strategies.
BBT also provided guidance and advice on the regulatory strategy for future iterations of the system.
Outcome
Successful market clearance of the newly internet-connected generation of the device. The improved processes and strategies were adopted by the client.
