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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
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.
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 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
Quantitative Benefit
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