Greenlight Guru > Case Studies > Tenacore's Successful ISO 13485:2016 Recertification Audit with Greenlight Guru's eQMS

Tenacore's Successful ISO 13485:2016 Recertification Audit with Greenlight Guru's eQMS

Technology Category

Platform as a Service (PaaS) - Application Development Platforms
Platform as a Service (PaaS) - Device Management Platforms

Applicable Industries

Equipment & Machinery
Healthcare & Hospitals

Applicable Functions

Maintenance
Quality Assurance

Use Cases

Virtual Training
Visual Quality Detection

Services

Testing & Certification
Training

About The Customer

Tenacore, LLC, founded in 2000 and headquartered in Costa Mesa, California, is one of the leading ISO 13485:2016-certified medical device repair and service companies in the United States. The company operates multiple service lines including patient monitoring, surgical, respiratory, and fluid delivery equipment. Tenacore's mission is centered around patient safety and quality, aiming to provide service and lifecycle solutions for hospitals and clinics to extend the lifespan of top-notch medical devices. The company has a growing list of over 100 medical device clientele and continues to expand its national coverage.

The Challenge

Tenacore, a leading ISO 13485:2016-certified medical device repair and service company in the United States, faced significant challenges with its paper-based Quality Management System (QMS). As the company continued to scale and manage over 100 medical devices, the paper-based QMS became increasingly difficult to manage. Crucial tasks such as obtaining Original Equipment Manufacturer (OEM) documentation, updating technical manuals, and managing and qualifying suppliers to meet Tenacore’s high-quality standards became exceptionally difficult. The paper-based system also hindered cross-team collaboration and created inefficiencies in their processes.

The Solution

To overcome these challenges, Tenacore adopted Greenlight Guru's easy-to-use electronic Quality Management System (eQMS). This platform provided Tenacore with the level of traceability needed to continue scaling operations. The cloud-based platform allowed the team to work from anywhere, streamlining their processes. Greenlight Guru’s task-based approach to QMS processes facilitated collaboration between their quality and product development teams, enabling them to move projects forward quicker. The eQMS also allowed Tenacore to link and reference information across the platform, ensuring better-connected processes and documentation. Within 10 months of purchasing Greenlight Guru, Tenacore migrated their entire QMS off of paper.

Operational Impact

The adoption of Greenlight Guru's eQMS has brought significant operational benefits to Tenacore. The company has become more efficient, passed audits, and reduced risk. The eQMS has enabled Tenacore to manage its processes more effectively on a daily basis, quickly identify gaps, and migrate their existing processes from a paper-based system. The platform has also facilitated better collaboration among teams and streamlined their work processes. Looking ahead, 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 continue to use Greenlight Guru as they scale operations across the United States.

Quantitative Benefit

Tenacore doubled in efficiency by 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.
Within 10 months of purchasing Greenlight Guru, Tenacore passed its ISO 13485:2016 audit with no major nonconformities.
The company reduced compliance risk by taking a risk-based approach to all of its quality operations.