• 4201 Wingren Dr #216 , Irving, TX, 75062
  • 972-795-2640

Medical Device

Good Validation starts with Good Automation

You don't have to be in the Medical Device industry long to learn...

Doing test validation optimally, always knowing where to focus, and getting the requirements right can take extreme time and effort.

What would things look like if it were always easy?

Meet Good Automation.

Good Automation is an expert in test method validation and software validation required by the FDA’s Quality System Regulation.

That means when we work together, you'll always get comprehensive validation documentation packages with your automated test system.

Good Automation is fluent with pre-market and post-market requirements from design inputs to complaint handling.

Medical Device Capabilities

  • Design Verification
  • Production Test Systems
  • Custom Validated Fixtures
  • Validation Planning
  • Protocol Development
  • Test Method Validation
  • Measurement System Analysis
  • Gage R&R
  • Mechanical Fixture Design
  • 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

"

Good Automation has helped us with several projects and has done a great job. They were able to work remotely to modify and write new LabVIEW software for our medical device and complete all the validation tasks as well. We could not find a better partner to help us.


Jacob Spector Manager, NPI & Lifecycle Engineering At Abiomed

contact us

>