Success Stories

Success Stories

Medical Standard Software Development

Medical Standard Software Development

A Real time health monitoring product required highly reliable IEC 62304 standard complaint software for FDA approval.

Solution Description

  • 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 development
  • SW maintenance
  • SW risk management
  • SW configuration management
  • SW problem resolution
Software Architecture 
  • 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.

System Description

Mobile App
  • Mobile app and user workflow was designed and developed  in line with the requirements of medical applications 
  • Integrated custom Heart rate/Respiration Rate algorithms.
  • Developed real time alerting in the event of critical medical events
  • Customized usage of OTS Heart rate algorithms.
  • High accurate output waveforms  by  stabilizing OTS software like coreplot enabling better  informed  decisions   for medical practitioners 
Embedded Firmware 
  • A highly reliable embedded firmware was developed with optimized code for maximum power saving so that  it can  operate on low power batteries.
  • Developed core DSP libraries that run-on fixed-point mode for usage in signal compression.
  • Implementation  fixed point CIC,FIR filters on cortex-M0.
  • The biosensor  data  extracted from ECG and Respiration sensors  are transferred using Wi-Fi by the means of a custom IPC between two cores of the SoC.
  • Design and development   of both embedded firmware and mobile app  in accordance with medical standards required for making the product complaint for FDA
  • Followed  IEC 62304 software life cycle process for development. 


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