C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)
Customer Company Size
SME
Region
- America
Country
- United States
Product
- Greenlight Guru MDQMS
- STIC Intra-Compartmental Pressure Monitor System
Tech Stack
- Electronic Quality Management System (eQMS)
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Customer Satisfaction
- Productivity Improvements
- Digital Expertise
Technology Category
- Functional Applications - Enterprise Asset Management Systems (EAM)
- Application Infrastructure & Middleware - Data Exchange & Integration
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Quality Assurance
- Business Operation
Use Cases
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- System Integration
- Training
About The Customer
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.
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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