Making quality software work for the business, not the other way around
Company Size
11-200
Region
- America
Country
- United States
Product
- Qualio
Tech Stack
- eQMS
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Asset Management Systems (EAM)
- Functional Applications - Enterprise Resource Planning Systems (ERP)
Applicable Functions
- Business Operation
- Quality Assurance
Services
- System Integration
- Training
About The Customer
TriMed is a California-based medical device manufacturer specializing in upper and lower extremity orthopedic implants. Their products help patients recover from musculoskeletal damage. The company has grown significantly, necessitating a robust quality management system to ensure compliance with various regulations such as FDA 21 CFR 820, ISO 13485, MDSA, and MDD CE marking.
The Challenge
TriMed initially used a paper-based quality management system, which became inefficient as the company grew. They then switched to a competitor's eQMS, which also proved to be inflexible and unable to scale with the company's growth. This led to widespread frustration and inefficiency, prompting the search for a more suitable eQMS platform.
The Solution
TriMed chose Qualio as their new eQMS platform in November 2021. Qualio provided a highly configurable and scalable quality system that met TriMed's needs. The implementation was quick, with the system going live by early December. Qualio's expert validation approach and hands-on support were key factors in the decision. The platform allowed for limitless configuration, aligning with TriMed's quality process preferences and freeing them from the constraints of their previous system.
Operational Impact
Quantitative Benefit
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