Surgical Stapler ATE - Good Automation

Multi-System ATE And V&V For A Fortune 100 Surgical Stapler Product Line

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A Fortune 100 medical device company needed automated test equipment for a multifunctional endoscopic stapler across handle and shaft assemblies, plus V&V across multiple test systems including closure force testers and design verification systems.

Good Automation designed and built ATE for handle and shaft assemblies, performed V&V on closure force testers and design verification systems, redeveloped test software to meet updated quality requirements, and extended V&V consulting to supply chain partners. Engagement spanned over 5 years.

Endoscopic stapler shaft design verification tester V&V

Redesigned verification tester V&V for test set for electromechanical endoscopic stapler.

Surgical stapler manufacturing support

Provided test engineering support for electromechanical stapler production test systems.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Stapler closure force test system V&V

Performed verification and validation of the closure force test system for endoscopic stapler subassembly testing.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Endoscopic stapler manufacturing ATE development

Developed test software for the endoscopic stapler product variant, extending the manufacturing ATE platform.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Endoscopic stapler handle manufacturing automated test equipment de…

Designed and developed the automated test equipment for production test of the handle of a multifunctional endoscopic stapler.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Stapler test software redevelopment and V&V

Redeveloped test software and performed verification and validation of test and measurement systems across the electromechanical stapler product line.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Stapler shaft manufacturing ATE software redevelopment

Redeveloped the manufacturing ATE software to improve reliability and comply with updated quality requirements.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Stapler shaft manufacturing ATE V&V

Performed complete verification and validation of the automated test equipment for use in production of an endoscopic stapler shaft.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

Stapler supply chain ATE V&V consulting services

Provided V&V consulting services for additional ATE systems in the endoscopic stapler manufacturing supply chain.

FDA Regulated Manufacturing Medical Device Safety Critical Test & Measurement

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Project Highlights

Multi-year, multi-system engagement inside a Fortune 100 quality system.
Demonstrates the full stack: ATE design, software development, V&V, software redevelopment, and supply chain support.