Making quality software work for the business, not the other way around
公司规模
SME
地区
- America
国家
- United States
产品
- Qualio
技术栈
- eQMS
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
技术
- 功能应用 - 企业资产管理系统 (EAM)
- 功能应用 - 企业资源规划系统 (ERP)
适用功能
- 商业运营
- 质量保证
服务
- 系统集成
- 培训
关于客户
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.
挑战
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.
解决方案
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.
运营影响
数量效益
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