Case StudyPatch Pump with Mobile Application
About This Project
Full Spectrum partnered with a client in the late stages of developing a patch pump with companion mobile app and cloud services for chronic disease management. The client was under significant schedule pressure, so they turned to Full Spectrum to address several documentation and compliance concerns ahead of their 510(k) submission. We worked with the client’s regulatory and development leads to identify and remediate gaps with respect to IEC 62304 and IEC 60601 compliance, and collaborated to ensure compliance with ISO 14971 by providing feedback on the Risk Management Plan and System Level Risk Assessment. Full Spectrum created detailed software FMEAs to determine the risk and required mitigations for custom and off-the-shelf software failures. We also performed a detailed analysis of the cloud architecture and use of third-party software-as-a- service (SaaS) solutions to ensure the correct processes were in place to ensure safety and security at the time of release and beyond.
- Challenges
- Approach & Solution
- Outcomes
• The client’s team was experienced in software design and development but lacked experience with the requirements for an FDA submission for a medical device connected to the cloud.
• The client’s regulatory team needed a better understanding of the system’s cloud architecture and how it might impact safety.
• The client did not have the in-house capacity to support compliance activities related to IEC 60601 and IEC 62304.
• Full Spectrum partnered with cross-functional leaders within the client’s organization to identify and review existing documentation and processes.
• After gaining an understanding of the system and its components, Full Spectrum performed software FMEAs to clearly document risks associated with software failures and required controls.
• Full Spectrum worked closely with the client’s cloud architecture group to document the back end of the system to meet the needs of both the internal regulatory team and their upcoming FDA submission.
• The system’s documentation meets the requirements for IEC 62304 and IEC 60601.
• The client’s regulatory and engineering leads have a shared understanding of the system’s operation and how its design protects patient safety.
• FDA documentation was focused on high- risk areas per FDA guidance.
• Client was able to hit their milestone for FDA 510(k) submission on time.