C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)
公司规模
SME
地区
- America
国家
- United States
产品
- Greenlight Guru MDQMS
- STIC Intra-Compartmental Pressure Monitor System
技术栈
- Electronic Quality Management System (eQMS)
实施规模
- Enterprise-wide Deployment
影响指标
- Customer Satisfaction
- Productivity Improvements
- Digital Expertise
技术
- 功能应用 - 企业资产管理系统 (EAM)
- 应用基础设施与中间件 - 数据交换与集成
适用行业
- 医疗保健和医院
- 生命科学
适用功能
- 质量保证
- 商业运营
用例
- 监管合规监控
- 远程资产管理
服务
- 系统集成
- 培训
关于客户
C2DX, Inc. is a medical device company headquartered in Schoolcraft, MI. The company specializes in diagnostic tools for monitoring compartmental pressure, particularly the STIC Intra-Compartmental Pressure Monitor System, which has been the Gold Standard for over 30 years. The team at C2DX, Inc. is composed of experienced professionals from the medical device industry, including Kevin McLeod, CEO, Amy Papranec, VP of Operations, Rick Huyser, VP of Engineering, and Ryan Eggleston, Director of Quality & Regulatory. The company values quality as the backbone of their organization and aims to deliver high-quality products while ensuring customer satisfaction.
挑战
C2DX, Inc. faced the challenge of ensuring a quality-first approach after acquiring a product from Stryker. They needed to establish a robust quality management system to maintain high standards, continue delivering a high-quality device, and provide the same customer experience that Stryker's customers had come to expect. Additionally, they aimed to implement an electronic quality management system (eQMS) that could support both their immediate needs and future growth.
解决方案
C2DX, Inc. decided to implement Greenlight Guru's medical device QMS (MDQMS) to establish a solid foundation for quality management. The decision was influenced by the team's prior experiences with manual processes and the need for a scalable, electronic solution. The implementation process was quick and intuitive, taking less than 30 days to set up an audit-ready system. The MDQMS facilitated various quality management activities, including document management, post-market quality event workflows, and design transfers to contract manufacturers. The system also made training and onboarding new hires easier, contributing to the company's overall efficiency and readiness for audits.
运营影响
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