Embedded Medical Device Firmware And V&V Engagements

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Embedded medical devices fail in the places where regulatory rigor and engineering reality collide. Firmware that ships without disciplined V&V cannot survive an audit. V&V that ignores the actual hardware behavior cannot catch the defects that matter to patients. The clients below each had embedded device work where both sides of that line had to be respected.

Good Automation engaged each client on the embedded engineering and the regulatory paperwork together: white-box FPGA testing tied to system-level V&V at a medical device electroporation company, a firmware and hardware rescue for an FDA-cleared precision IR thermometer threatened by field failures, and GUI design plus non-product software V&V for a Class II electromagnetic implant treatment device. Three different devices, one consistent approach: do the engineering correctly the first time, and document it well enough that the regulator never has a reason to doubt it.

Biofilm-killing electromagnetic implant device GUI and V&V

For Class II Electromagnetic Therapy Startup: Designed the GUI and performed verification and validation for a Class II post-surgical treatment device that uses electromagnetic fields to induce eddy currents on the surface of hip, knee, and shoulder implants to kill bacterial biofilm at the implant boundary,

Medical device FPGA white-box testing and V&V

For Medical Device Electroporation Company: Performed white-box testing for FPGA-based systems at the client.

Embedded Systems FDA Regulated Hardware Medical Device Verification & Validation

Precision IR thermometer firmware and hardware rescue

For Consumer Electronics Startup: Performed rapid fixes of firmware and hardware for a consumer electronics company developing a precision IR thermometer with 0.1 degree Celsius accuracy.

Consumer Electronics Embedded Systems FDA Regulated Hardware

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Project Highlights

3-project engagement covering complementary scopes under one engineering relationship.
Capability mix: Consumer Electronics, Embedded Systems, FDA Regulated, Medical Device, Verification & Validation.
Work performed in the context of FDA quality system requirements where the customer's regulatory framework demanded it: non-product software V&V per 21 CFR 820.70(i) and electronic-records compliance per 21 CFR Part 11 as applicable.