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# Medical Device Companies Need Closed-Loop Traceability: Column
- URL: https://www.fdaweb.com/medical-device-companies-need-closed-loop-traceability-column/
- Published: 2021-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:01:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149440

Greenlight Guru founder **Jon Speer** says medical device companies need closed-loop traceability (CLT) to demonstrate identification and traceability in all quality system processes and thus comply with FDA regulations. Writing in an online *Quality Digest* [column](https://www.qualitydigest.com/inside/fda-compliance-column/closed-loop-traceability-fda-compliance-060221.html?ref=fdaweb.com), Speer says that with a global regulatory emphasis on CLT, it’s up to medical device companies to ensure their systems can keep pace with the expectation. He says companies have access to modern quality management system solutions that increase the accuracy and speed of demonstrating CLT, creating opportunities to remain compliant as well as to improve their operations and competitive edge in the market.