Tenacore Passes ISO 13485:2016 Recertification Audit with the Help of Greenlight Guru’s Modern Platform

Tenacore, LLC is one of the leading ISO 13485:2016-certified medical device repair and service companies in the United States. 

When choosing an eQMS partner, Tenacore needed an intuitive platform that would help them continue to grow their business, successfully navigate audits, maintain documentation, manage suppliers, and drive collaboration between their various teams.

Tenacore, LLC: Quality at the Core 

Tenacore is a California-based medical device repair company that operates multiple service lines including patient monitoring, surgical, respiratory, fluid delivery equipment, and more. Since 2000, the company has continued to expand its national coverage and support its growing list of 100+ medical device clientele. 

The company's mission is centered around patient safety and quality. Tenacore aims to provide service and lifecycle solutions for hospitals and clinics so that top-notch medical devices can have a longer lifespan. 

Challenge: Paper-based QMS

Tenacore realized that managing quality activities on paper and spreadsheets doesn’t always work and made cross-team collaboration increasingly difficult. 

Suddenly, the company’s simple, yet crucial tasks like obtaining the Original Equipment Manufacturer (OEM) documentation or updating technical manuals became exceptionally difficult. They also discovered inefficiencies with paper when managing and qualifying suppliers to ensure they met Tenacore’s high standards for quality. 

The Solution: Greenlight Guru

Having better-connected processes and documentation was incredibly important for the Tenacore team. Greenlight Guru’s ability to link and reference information across the platform provided Tenacore with the level of traceability needed to continue scaling operations. The team also needs the flexibility to work from everywhere, which is streamlined with Greenlight Guru’s cloud-based platform. Greenlight Guru’s task-based approach to QMS processes helps their quality and product development teams collaborate and move projects forward quicker.

The Results: Benefits of using Greenlight Guru

Tenacore has gained a partnership that is more than just software. They have become more efficient, passed audits, and reduced risk.

2x More Efficient 

Replacing disconnected processes and tools with Greenlight Guru as the source of truth for their Documents, Change Management, Audits, CAPA, Nonconformance, Customer Feedback, Training, and more has doubled employee efficiency. 

0 Major Nonconformances: ISO 13485:2016 Recertification Audit

Within 10 months of purchasing Greenlight Guru, Tenacore passed its ISO 13485:2016 audit with no major nonconformances. 

“This was the first time in years Tenacore had no major observations in an ISO audit. We have Greenlight Guru to thank for that” - Riley Van Hofwegen, CCO 

Reduced Compliance Risk 

Tenacore takes a risk-based approach to all of its quality operations. The same was true when choosing an eQMS vendor.  

"Using a QMS vendor that does not focus its platform development on the medical device industry introduces a risk we are not willing to take. Greenlight Guru is built for medical devices and that is why we trust them." - Alfonso Canto, QA Manager

Easy-to-use eQMS 

Being siloed in a paper-based system was hard with how many processes Tenacore has to manage on a daily basis. With Greenlight Guru’s easy-to-use eQMS, they were able to migrate their existing processes over and quickly identify where they had gaps. 

“Working with the Greenlight Guru team is hands-on. In the beginning, it felt like we went through an entire master class in our QMS. ” - Alfonso Canto, QA Manager

     

What’s Next for Tenacore?

Tenacore is committed to putting its patients, customers, and quality at the core of everything, even at an executive level. Their senior leadership team will be taking Greenlight Guru Academy certification courses on Intro to ISO 13485 and Intro to 21 CFR Part 820  in 2023 to uphold this commitment. The company will be continuing to use Greenlight Guru as they scale operations across the United States.