Six weeks, three audits, and no stress: how MediBeacon impressed auditors with Greenlight Guru

Who is MediBeacon?

MediBeacon is a medical technology company specializing in the advances of fluorescent tracer agents and transdermal measurement. Accurate physiological measurements made in real-time are vital in the hospital as well as in the management of chronic diseases, and MediBeacon’s goal is to provide clinically relevant information that can cost effectively and positively impact patient care.

MediBeacon's focus areas span nephrology, gastroenterology, ophthalmology, and surgery, with potential applications targeting major unmet patient needs. The MediBeacon TGFR™ System is engineered to detect the change in levels of a fluorescent GFR tracer agent over time via a sensor placed on the patient’s skin. The TGFR™ Monitor displays this information in the form of a transdermal GFR (tGFR).

The challenge: three audits in six weeks

MediBeacon has relied on Greenlight Guru for years to get them safely through audits, but the number of audits they faced in a recent six-week span was an extra challenge. At the beginning of the year, MediBeacon held an internal audit, which was followed by a stage one MDR audit with their notified body. After that, the team underwent an audit that covered ISO 13485 surveillance, MDSAP surveillance, and MDR certification.

That would be a tall order for any team. Fortunately, MediBeacon had everything they needed to not only pass the audits but impress their auditors.

The solution: Greenlight Guru’s eQMS

Kallen Withers, Project Leader at MediBeacon, became the company's resident Greenlight Guru expert almost five years ago. She inherited the system as the established eQMS and has since expanded its use to include document control, training, suppliers, CAPAs, non-conformance, and customer feedback.

Using one system for everything means Withers can quickly pull any record or procedure for auditors in real time. “One thing auditors are always complimentary of within our system is that everything is easily referenced. We can link things together and it helps a ton during the audit to make things go smoothly,” said Withers.

That’s a huge difference from the experience Withers had in a previous role, at a company that used a paper-based quality system. There, audit time was a high-stress scramble to find and print documents. With Greenlight Guru, Withers can show auditors items like CAPA workflows in real time, clicking through sources to immediate actions and root causes to demonstrate compliance in real-time.

The results: less audit prep and happy auditors

While audits are never exactly fun, Withers appreciates how Greenlight Guru dramatically reduces the time it takes to prepare for them. There is always some degree of audit prep, but Greenlight Guru makes it easy for Withers to pull what she knows she’ll need ahead of time and quickly check training, supplier evaluations, and other documentation.

Auditors appreciate how easy it is to find documents and records within Greenlight Guru, too. According to Withers, auditors aren’t just familiar with Greenlight Guru, they also think it’s a great system for medtech companies to use.

Of course, lower stress and easy audits are great, but the results of those audits are what really matter. And even with such a tight schedule, MediBeacon successfully passed all of their audits.

Why Greenlight Guru: medtech-specific with excellent customer support

Though Withers inherited Greenlight Guru, she says they’ve never considered changing systems. Part of that is because Greenlight Guru is built specifically for medical device companies like MediBeacon.

“One thing that makes Greenlight Guru so good for us is that it’s so specific to medical devices,” Withers said. The team prefers having a system that’s built for their needs, instead of having to customize general-purpose QMS software.

That’s an important part of creating a right-sized quality system, according to Withers. “Some companies need a really big, complex quality system. And you can use Greenlight Guru for that. But you can also use it for small companies that are just getting started and just developing their quality system.”

Withers said the team has also appreciated Greenlight Guru’s clear validation package that eliminates much of the labor involved with other QMS solutions that aren’t specific to medtech.

Finally, MediBeacon continues to choose Greenlight Guru because of the continued development of the platform and the expert support they get along the way. Withers appreciates the quick and responsive communication from the customer success team and the rapid pace of new features and functionality.

What’s next for MediBeacon?

MediBeacon just launched a new product in the United States and China and is working on future generations of products. Kallen is now populating the design controls workspace for products MediBeacon will own end-to-end. The confidence to take that step comes directly from how the rest of the system has held up.