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实例探究 > Solid foundation for quality and the ability to grow with their company

Solid foundation for quality and the ability to grow with their company

技术
  • 功能应用 - 企业资源规划系统 (ERP)
  • 功能应用 - 产品生命周期管理系统 (PLM)
  • 功能应用 - 远程监控系统
适用行业
  • 医疗保健和医院
  • 生命科学
适用功能
  • 产品研发
  • 质量保证
用例
  • 质量预测分析
  • 监管合规监控
  • 远程资产管理
服务
  • 软件设计与工程服务
  • 系统集成
  • 培训
挑战
In a previous R&D role at a medical device company, Emil had worked with a paper-based quality management system where they also leveraged digital tools, like Excel, to manage their device requirements. This experience proved to be cumbersome, time-consuming, and full of complexity when it came to maintaining traceability and version control. While starting FlexLogical, Emil had a strong sense of the importance of implementing a digital quality system. As they began solidifying their device concepts and adding more team members to focus on risk and developing their QMS, Emil wanted to assure they approached quality the right way. Emil knew that “using excel would be too comprehensive” for their devices and would not support the integrity and quality of the devices they want to produce – leading to more cumbersome work in the long run.
关于客户
FlexLogical is a medical device company based in Copenhagen, Denmark, co-founded by Emil Cederfeldt. The company focuses on developing innovative laparoscopic devices designed to enhance surgeons' performance by increasing postural freedom, minimizing strain, and reducing muscle fatigue. This ultimately improves overall surgical performance and minimizes work-related musculoskeletal injuries suffered by surgeons. FlexLogical aims to revolutionize surgical technology by prioritizing quality from the beginning and implementing the right Quality Management System (QMS) to ensure the integrity and quality of their devices. The company targets markets in Scandinavia, Germany (EU MDR), and the USA (FDA).
解决方案
FlexLogical identified several needs in a QMS software solution to make their team successful in managing quality. The features and capabilities they were looking for include: supporting the complexity and multitude of device requirements, enabling full product lifecycle traceability, assuring correct documentation and controls, and being easy to learn, implement, and use. The team at FlexLogical was focused on finding and establishing a QMS software that would set them up for success from the start. They hired a Quality Manager with previous experience with Greenlight Guru’s MDQMS, who recommended the software for Emil to consider. After a software demonstration, Greenlight Guru proved to be an intuitive system that would make quality management easy to learn for their team. Emil was especially drawn to how they could document traceability around their design controls and risk management within Greenlight Guru. The ability to learn how to manage the quality system just by using it ultimately helped Emil decide that Greenlight Guru’s MDQMS would be the best fit for FlexLogical.
运营影响
  • Quick implementation of an easy-to-use MDQMS platform: FlexLogical was fully onboarded and using the system assuredly within just 5 training sessions, surpassing their expectations and timeline for implementing a QMS.
  • Streamlined processes: Building out design control and risk matrices in Greenlight Guru provided clear visibility into their quality system, allowing them to easily find the information needed.
  • Data-driven quality: The MDQMS enabled thorough documentation and acted as a single source of truth, allowing the FlexLogical team to work collaboratively and effectively.
数量效益
  • Fully onboarded and using the system within just 5 training sessions.
  • Reduced audit preparation time from 2-3 weeks to mere seconds for displaying and sharing documents.

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