Download PDF
Greenlight Guru: Revolutionizing Quality Management Systems in Medical Device Industry
Technology Category
- Cybersecurity & Privacy - Security Compliance
- Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
- Electronics
- Healthcare & Hospitals
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Inventory Management
- Visual Quality Detection
Services
- Testing & Certification
- Training
The Challenge
Medical device companies often struggle with managing their Quality Management Systems (QMS), Design Controls, and Risk Management. The challenges are often at two extremes: either the QMS is deficient and does not address regulations, or it meets regulations but is overly complicated. Both scenarios pose potential problems. A deficient QMS is a compliance risk that must be avoided, while an overly complicated QMS may not be followed as prescribed, leading to non-compliance. Additionally, companies often struggle with documenting Design Controls during product development, making the process unnecessarily complicated. The medical device regulatory world is also shifting its focus towards risk management, requiring QMS to implement risk-based approaches. This shift has left many companies struggling to keep up with the new regulatory focus.
About The Customer
Greenlight Guru's customers are medical device companies that are struggling with managing their Quality Management Systems (QMS), Design Controls, and Risk Management. These companies are often at risk of non-compliance due to deficient or overly complicated QMS. They also struggle with documenting Design Controls during product development and keeping up with the shifting regulatory focus towards risk management. Greenlight Guru's customers are looking for a solution that is simple, scalable, and flexible, and that can help them manage their QMS, Design Controls, and Risk Management effectively and efficiently.
The Solution
Greenlight Guru provides a comprehensive solution to these challenges. It offers software solutions that help medical device companies manage their QMS, Design Controls, and Risk Management. The software is designed to be simple, scalable, and flexible, ensuring that it is right-sized for the company. Greenlight Guru also provides all the required QMS procedures, forms, and templates, along with QMS training and guidance. To address the challenge of documenting Design Controls, Greenlight Guru has designed a solution to streamline the process, focusing on the actual content and ensuring complete traceability. As the medical device regulatory world shifts its focus towards risk management, Greenlight Guru is at the forefront of this movement, ensuring that its solutions are up to speed with current and future regulatory viewpoints. It allows for the full integration of risk management efforts with Design Controls and product development practices.
Operational Impact
Quantitative Benefit
Related Case Studies.
Case Study
Remote Temperature Monitoring of Perishable Goods Saves Money
RMONI was facing temperature monitoring challenges in a cold chain business. A cold chain must be established and maintained to ensure goods have been properly refrigerated during every step of the process, making temperature monitoring a critical business function. Manual registration practice can be very costly, labor intensive and prone to mistakes.
Case Study
Hospital Inventory Management
The hospital supply chain team is responsible for ensuring that the right medical supplies are readily available to clinicians when and where needed, and to do so in the most efficient manner possible. However, many of the systems and processes in use at the cancer center for supply chain management were not best suited to support these goals. Barcoding technology, a commonly used method for inventory management of medical supplies, is labor intensive, time consuming, does not provide real-time visibility into inventory levels and can be prone to error. Consequently, the lack of accurate and real-time visibility into inventory levels across multiple supply rooms in multiple hospital facilities creates additional inefficiency in the system causing over-ordering, hoarding, and wasted supplies. Other sources of waste and cost were also identified as candidates for improvement. Existing systems and processes did not provide adequate security for high-cost inventory within the hospital, which was another driver of cost. A lack of visibility into expiration dates for supplies resulted in supplies being wasted due to past expiry dates. Storage of supplies was also a key consideration given the location of the cancer center’s facilities in a dense urban setting, where space is always at a premium. In order to address the challenges outlined above, the hospital sought a solution that would provide real-time inventory information with high levels of accuracy, reduce the level of manual effort required and enable data driven decision making to ensure that the right supplies were readily available to clinicians in the right location at the right time.
Case Study
Gas Pipeline Monitoring System for Hospitals
This system integrator focuses on providing centralized gas pipeline monitoring systems for hospitals. The service they provide makes it possible for hospitals to reduce both maintenance and labor costs. Since hospitals may not have an existing network suitable for this type of system, GPRS communication provides an easy and ready-to-use solution for remote, distributed monitoring systems System Requirements - GPRS communication - Seamless connection with SCADA software - Simple, front-end control capability - Expandable I/O channels - Combine AI, DI, and DO channels
Case Study
Driving Digital Transformations for Vitro Diagnostic Medical Devices
Diagnostic devices play a vital role in helping to improve healthcare delivery. In fact, an estimated 60 percent of the world’s medical decisions are made with support from in vitrodiagnostics (IVD) solutions, such as those provided by Roche Diagnostics, an industry leader. As the demand for medical diagnostic services grows rapidly in hospitals and clinics across China, so does the market for IVD solutions. In addition, the typically high cost of these diagnostic devices means that comprehensive post-sales services are needed. Wanteed to improve three portions of thr IVD:1. Remotely monitor and manage IVD devices as fixed assets.2. Optimizing device availability with predictive maintenance.3. Recommending the best IVD solution for a customer’s needs.
