MediBeacon passes three audits in six weeks with zero major findings using Greenlight Guru

Medical device company relied on Greenlight Guru’s eQMS to stay audit ready across ISO 13485, MDSAP, and MDR reviews

INDIANAPOLIS, Sept. 14, 2026 /PRNewswire/ — Greenlight Guru, the leading provider of quality management, product development, and clinical data solutions for medical device companies, today announced that longtime customer MediBeacon passed three audits in a six-week span with zero major findings, using Greenlight Guru’s eQMS to manage every stage of preparation and review.

MediBeacon Inc., a medical technology company specializing in fluorescent tracer agents and transdermal measurement, faced an internal audit, a stage one MDR audit with its notified body, and a combined review covering ISO 13485 surveillance, MDSAP surveillance, and MDR certification, all within six weeks. Kallen Withers, project leader at MediBeacon, has managed the company’s quality system in Greenlight Guru for nearly five years, using it for document control, training, supplier management, CAPAs, nonconformance, and customer feedback.

“One thing auditors are always complimentary of within our system is that everything is easily referenced,” said Withers. “We can link documents together and it helps a ton during the audit to make things go smoothly.”

That traceability marked a sharp contrast with Withers’ experience at a previous company that ran its quality system on paper, where audit time meant a high-stress scramble to find and print documents. This time MediBeacon passed all three audits with significantly less stress, and auditors themselves noted familiarity with the platform and confidence in its fit for medical device companies.

“MediBeacon has never considered switching systems,” Withers said, “because Greenlight Guru is built specifically for medical device companies rather than adapted from general-purpose quality software.” The company recently launched a new product in the United States and China and is now building out design controls for future products, a step Withers credits directly to how the rest of the system has held up under audit pressure.

The full MediBeacon story is available at greenlight.guru/medibeacon-case-study-two.

About Greenlight Guru

Greenlight Guru builds software for medical device companies, and only for medical device companies. Trusted by more than 1,100 medical device companies worldwide, Greenlight Guru provides quality management, product development, and clinical data solutions backed by people who have done the work. For more information, visit greenlight.guru.

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SOURCE Greenlight Guru