More Case Studies

AJ MEDICAL

Subcutaneous Cardio Monitor

As an implantable device, this device required innovative packaging and chip construction. It was designed to automatically detect cardiac arrest and use a wirelessly-connected pager-like device to alert bystanders and call 911. The project also required digital signal processing, RF design, and algorithm design.

This device has:

  •  Advanced arrhythmia detection

  • RF links

  • Custom ASIC

  • Embedded cellular development

  • Multichannel ECG acquisition system

  • Advanced DSP based arrhythmia detection

  • MICS band RF system communication to smart phone peripheral

We also assisted AJ Medical Devices in the creation and submission of a 510K.

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WE DELIVERED

  • Architecture design

  • Systems engineering

  • IoT Development

  • Requirements capture and traceability

  • DHF documentation

  • Risk analysis

  • Agency testing requirements, analysis and pre-testing

  • Industrial design

  • Mechanical engineering

  • Electrical engineering

  • ASIC specification, interface to engineering and fabrication

  • Unit testing of custom ASIC

  • Software engineering

  • Advanced detection algorithms for multiple conditions/events

  • Prototyping, rapid turn PCB

  • Preliminary agency testing

  • Integration and testing

  • Agency testing, UL, FCC, EU

  • System and software test protocols

  • Software unit testing and unit integration testing

  • Compliance with EN62304 software life cycle standards

  • Verification: system, hardware and software

  • EMC compliance and mitigation

  • 60601-1-2 and FCC, EU certification oversight

  • Production support and fixturing

  • Device programmer PC application

  • Data push to monitoring service

  • Clinical human data gathering and analysis

  • Comparative trial setup and execution

  • Implemented production equivalent manufacturing cell

  • FDA submission (510K)