Medical Device

Good Automation is an expert in test method validation and software validation required by the FDA’s Quality System Regulation. We include comprehensive validation documentation packages with your automated test system. We are fluent with premarket and postmarket requirements from design inputs to complaint handling.  Grill us.  We know our stuff and would love to help you.

  • Design Verification
  • Production Test Systems
  • Custom Validated Fixtures
  • Validation Planning
  • Protocol Development
  • Test Method Validation
  • Measurement System Analysis
  • Gage R&R
  • Process Validation IQ/OQ/PQ
  • Draft and Audit your SOP’s and work instructions
  • Part 11 Validation (with clever approaches to both e-records and e-signatures)
  • Requirements Traceability
  • Risk Management
  • Automated Test Equipment (ATE)
  • Data Acquisition and Data Management
  • Cybersecurity
  • National Instruments LabVIEW, LabWindows/CVI, TestStand
  • National Instruments PXI, CompactRIO
  • C/C++/C#, Python, Java, and additional software languages
  • Rack-and-stack instrumentation
  • Electrical circuit design
  • FDA Regulatory Compliance (21CFR820.70, 21CFR820.72, 21CFR11)
  • Quality Management System (QMS) development and audit
  • Mechanical Fixture Design
  • Contact Us

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