"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 ManagerEasy-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

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Within 10 months of purchasing Greenlight Guru, Tenacore migrated their entire QMS off of paper and passed their ISO 13485:2016 Recertification Audit with zero major nonconformities.

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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.

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.

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.

This eBook compares the best QMS software solutions to help medical device companies make an informed decision when investing in a quality management system.

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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.

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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.

Modernize your QMS and achieve peace of mind heading into your next audit knowing you have a solution that has done it before.

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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.

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

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Greenlight Guru provides an easy-to-use eQMS that helps the Tenacore team easily collaborate and manage processes for 100+ medical devices.

0 Major Nonconformances: ISO 13485:2016 Recertification AuditWithin 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.

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Managing audits and documentation in a paper-based QMS became increasingly challenging as the company continued to scale.

Tenacore had a successful ISO 13485:2016 audit, doubled in efficiency, reduced risk, and continues to recieve world-class industry training.