Good Automation
Book Technical Risk Review

Test Method And Measurement V&V Across Regulated Production

Discover The Projects

FDA quality systems require evidence that the tools used to make and measure regulated products actually do what they say they do. Production-line inspection systems, in-vitro diagnostic test methods, and operational software like a Learning Management System all need to clear that bar. The clients below each had one specific tool to qualify under 21 CFR 820, and a real timeline to do it on.

Good Automation took each scope on its own terms: uncertainty analysis, Measurement System Analysis, and an in-situ process gauge design for a CAPA-driven orthopedic implant inspection system; IEC 62304 software V&V and test method V&V for a breast cancer screening in-vitro diagnostic; and non-product software validation for a commercial off-the-shelf Learning Management System used at a Class II cardiac device manufacturer. Three different production contexts, one consistent posture: the V&V evidence has to be defensible against the regulator who will read it, not just internally satisfying.

CAPA-driven orthopedic implant automated inspection system

For Class II Orthopedic Implant Manufacturer: Designed an automated inspection solution for a Class II orthopedic implant manufacturer producing shoulder, knee, and hip implants.
FDA RegulatedMachine VisionManufacturingMedical Device

Breast cancer screening IVD V&V

For Breast Cancer IVD Startup: Performed verification and validation of In Vitro Diagnostic (IVD) medical device for breast cancer screening.
FDA RegulatedMedical DeviceVerification & Validation

FDA-compliant LMS validation for medical device training

For Class II Cardiac Device Manufacturer: Performed non-product software validation per 21 CFR 820.70(i) for a commercial off-the-shelf (COTS) Learning Management System at a Class II medical device company.
FDA RegulatedMedical DeviceVerification & Validation

Trusted by

Medtronic GD Energy Products Bell Helicopter Johnson & Johnson GE Healthcare Halliburton Shell Stryker Alcon Abbott Qorvo Qualcomm Keysight Technologies National Instruments MIT Oak Ridge National Lab Ethicon Bridgestone IBM U.S. Department of Energy Georgia Tech Stanford University University of Texas at Austin Verb Surgical Berkeley Lab Pacific Northwest Lab Hewlett Packard Enterprise Gardner Denver Lockheed Martin

Project Highlights

  • 3-project engagement covering complementary scopes under one engineering relationship.
  • Capability mix: FDA Regulated, Machine Vision, Manufacturing, 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.
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