Grumpy Innovations
IEC 62304 Software Verification & Compliance
To support the development of a novel algorithm for estimating glucose trends from SpO₂ plethysmographic data, Bodimetrics partnered with Garrett Technologies, Inc. for an end-to-end research and software development initiative. The client needed robust algorithm design, a verified toolchain, and FDA-ready documentation for submission. Garrett Technologies, Inc. delivered a multi-phase development effort integrating clinical data analysis, software verification, and comprehensive database handling to support algorithm training and validation.
Garrett Technologies, Inc. collaborated closely with Bodimetrics to produce validated, performance-driven algorithms and tools—paving the way for regulatory clearance and future product integration.
WE DELIVERED
System feasibility study using known patient data
Signal analysis of SpO₂ waveform trends and amplitude estimation ·
Python/Jupyter-based exploratory data analysis ·
Toolchain architecture and development for data marking and classification · Design and verification of an SpO₂ annotation tool ·
Automated test framework: database → algorithm → output validation ·
Pulsatile segment identification and clinician-guided classification ·
Development and validation of custom statistical metrics ·
Long-term amplitude trend analysis (absolute vs. relative tracking) ·
Algorithm development including glucose estimation logic ·
Discriminator and issue resolution for algorithm robustness ·
Comprehensive test plan for FDA submission ·
Database creation, overread, and annotation integration ·
Software and tool verification against DHF requirements ·
Integration and testing of user interface components ·
Structured regression and contingency verification process ·
Full verification documentation: unit test plan, tool validation, performance reporting ·
Final data packaging per FDA submission standards
