Solid foundation for quality and the ability to grow with their company
Company Size
11-200
Region
- America
- Europe
Country
- Denmark
- Germany
- United States
Product
- Greenlight Guru MDQMS
Tech Stack
- Digital Quality Management System (QMS)
Implementation Scale
- Enterprise-wide Deployment
Impact Metrics
- Cost Savings
- Customer Satisfaction
- Digital Expertise
- Productivity Improvements
Technology Category
- Functional Applications - Enterprise Resource Planning Systems (ERP)
- Functional Applications - Product Lifecycle Management Systems (PLM)
- Functional Applications - Remote Monitoring & Control Systems
Applicable Industries
- Healthcare & Hospitals
- Life Sciences
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Predictive Quality Analytics
- Regulatory Compliance Monitoring
- Remote Asset Management
Services
- Software Design & Engineering Services
- System Integration
- Training
About The Customer
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).
The Challenge
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.
The Solution
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.
Operational Impact
Quantitative Benefit
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