A Real time health monitoring product required highly reliable IEC 62304 standard complaint software for FDA approval
Gadgeon developed embedded firmware and mobile app for real time ECG and respiration monitoring in accordance with medical standards required for making the product complaint for FDA
Followed IEC 62304 software life cycle process for development with all the mandatory documentation.
Multichannel ECG and Respiration data from the body-worn sensor is reliably transmitted over Wi-Fi to the Mobile App
Embedded firmware was developed with optimized code for maximum power saving so that it can operate on low power batteries.
Outcome and Benefits Delivered
The patch could work on coin cell batteries for multi day operation as the embedded biosensor firmware was written in highly efficient and power optimized way
Mobile app and user workflow was designed and developed in line with the requirements of medical practitioners
Highly accurate waveforms display in the App enabling better informed decisions for healthcare givers .
Real time alerting in the event of critical medical events
The Solution / System Description
Gadgeon developed medical complaint software by taking software development through all phases of IEC 62304
IEC 62304 – Medical software life cycle process to cover
SW risk management
SW configuration management
SW problem resolution
Architected the entire solution and provided the appropriate risk mitigation solution for developing the embedded firmware and mobile application.
This includes Requirement, Gathering & Analysis, Uses cases, Architecture development, identification of functional identification OTS for embedded firmware and mobile app and verification strategy. Risk analysis and Risk mitigation plans for software components was done.
Mobile app and user workflow was designed and developed in line with the requirements of medical applications
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