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

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

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

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
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. Read More
About 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). Read More
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. Read More Log in to view content
Contents

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

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.

About 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).

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.

Impact #1	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.
Impact #2	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.
Impact #3	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.

Impact #1

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.

Impact #2

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.

Impact #3

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.

Benefit #1	Fully onboarded and using the system within just 5 training sessions.
Benefit #2	Reduced audit preparation time from 2-3 weeks to mere seconds for displaying and sharing documents.

Benefit #1

Fully onboarded and using the system within just 5 training sessions.

Benefit #2

Reduced audit preparation time from 2-3 weeks to mere seconds for displaying and sharing documents.

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Overview

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

Operational Impact

Quantitative Benefit