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.

Want to be sure? Grill us.

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

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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