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All Case Studies/Medical Devices / Healthcare Technology
PORTFOLIO CASE STUDYMedical Devices / Healthcare TechnologyDomain: Point-of-Care Diagnostic Firmware & Medical Lifecycle V&VEngagement: Medical Device Verification & Lifecycle Pod

Preparing a Portable Diagnostic Device for Safer Releases

Specialized Engineering Scope & Mission Challenge

A diagnostic equipment maker was developing an automated, portable blood analysis device for emergency clinics and ambulances. The device utilized a motorized microfluidic cartridge, optical absorbance sensors, and an embedded touchscreen running under tight thermal and timing constraints. With an upcoming 510(k) submission deadline, the engineering organization struggled to compile formal verification evidence. Firmware updates frequently broke regression tests on mechanical cartridge eject sequences, and requirement-to-risk matrices were scattered across ad-hoc spreadsheets.

Granular Competency & Technical Requirement Matrix

IEC 62304 Software Lifecycle Process Management (Class C Safety)
ISO 14971 Medical Device Risk Management & FMEA Integration
Motor & Actuator Motion Control (Stepper / DC Servo Control)
Optical Sensor Ingestion & Calibration Algorithms
MISRA C:2012 Static Code Analysis & Unit Test Coverage
Automated Test Fixture Engineering for Diagnostic Cartridges

Critical Engineering & Integration Complexities

  • Multi-processor coordination between an RTOS real-time motion controller and a Linux-based graphical user interface.
  • Class C software safety hazard mitigation—preventing erroneous reagent dispensing or laser over-exposure under any software fault.
  • Stringent environmental operating constraints for ambulance transit (temperature swings, mechanical shock, vibration).
  • Ensuring 100% test traceability across software requirements, risk controls, and automated test execution logs.

Engineered Delivery & Execution Workflow

01

IEC 62304 Lifecycle Alignment

Mapped all software units, architecture modules, and risk control measures into a formalized traceability matrix.

02

Inter-Processor Protocol Hardening

Designed a CRC-protected UART protocol with deterministic heartbeat supervision between GUI and motor controllers.

03

Closed-Loop Motion Control

Refined micro-stepping algorithms for syringe and cartridge actuators, eliminating mechanical jams.

04

Static Code Hardening

Remediated MISRA C:2012 violations and integrated automated static analysis into every pull request.

05

Automated Verification Fixture

Built an automated mechanical test rig simulating cartridge insertions, optical faults, and door tampering.

06

Risk Control Verification

Validated every software mitigation against simulated hardware faults defined in the ISO 14971 FMEA.

07

Design History File (DHF) Generation

Produced audit-ready software verification reports and traceability documentation for FDA review.

Production Toolchains, Protocols & Frameworks

IEC 62304 workflowEmbedded C/C++Static analysisAutomated test benchFreeRTOSLinux

06 | PROJECT TARGETS

Project Targets and Business Impact

100%
Requirement coverage target
Target for this engagement.
2x
Regression throughput target
Target for this engagement.
-25%
Retest cycle time target
Target for this engagement.
0
Unresolved high-severity release blockers target
Target for this engagement.
Business Impact Statement: The program emphasizes reproducible verification and change traceability, accelerating FDA 510(k) readiness and eliminating late regression cycle slips.

Customer Confidentiality Note: Customer identity, proprietary codebases, and commercial program specifics have been anonymized in accordance with non-disclosure agreements.