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实例探究 > C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

C2DX, Inc. Impresses Auditors and Achieves MDSAP Certification After Implementing Medical Device QMS (MDQMS)

技术
  • 应用基础设施与中间件 - 数据交换与集成
  • 功能应用 - 企业资产管理系统 (EAM)
适用行业
  • 医疗保健和医院
  • 生命科学
适用功能
  • 商业运营
  • 质量保证
用例
  • 监管合规监控
  • 远程资产管理
服务
  • 系统集成
  • 培训
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.
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.
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
  • The implementation of Greenlight Guru's MDQMS allowed C2DX, Inc. to streamline their quality management processes, making it easier to manage documents, revisions, and signatures.
  • The system facilitated design transfers to contract manufacturers, ensuring a smooth transition and maintaining high-quality standards.
  • Training and onboarding new hires became more efficient, thanks to the intuitive and user-friendly nature of the MDQMS.
数量效益
  • C2DX, Inc. achieved FDA approval within 30 days of implementing the MDQMS.
  • The company successfully obtained MDSAP and ISO certifications shortly after implementing the system.

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