Monitored Therapeutics, Inc: Streamlining Regulatory Compliance with Greenlight Guru
Technology Category
- Networks & Connectivity - Bluetooth
- Platform as a Service (PaaS) - Device Management Platforms
Applicable Industries
- Education
- Pharmaceuticals
Applicable Functions
- Product Research & Development
- Quality Assurance
Use Cases
- Remote Patient Monitoring
- Visual Quality Detection
Services
- Testing & Certification
- Training
About The Customer
Monitored Therapeutics, Inc. (MTI) is an Ohio-based MedTech company that sells proprietary diagnostic products globally. Founded in 2011, the company has between 25-50 employees and is headquartered in Dublin, Ohio, USA. MTI has developed a powerful cloud-based system that enables their devices to share accurate patient data with clinicians in real-time. Their flagship product, GoSpiro, is a Bluetooth spirometer that allows patients to get lab-quality diagnostics from home at a significantly lower cost. MTI's mission is to extend access to care to patients through a standardized technology platform, while decreasing the cost of healthcare by allowing patients access to healthcare from the comfort of their homes.
The Challenge
Monitored Therapeutics, Inc. (MTI), a remote patient monitoring company specializing in respiratory diseases, faced significant challenges in navigating the global regulatory landscape. The complexity of maintaining compliance while distributing products globally was a daunting task. The company was also preparing for several audits, including FDA, ISO 13485, MDSAP, and customer audits. The challenge was to find a Quality Management System (QMS) that was not just a tool, but a comprehensive solution that could guide and support them through these audits. Additionally, as MTI began to scale, cost became a significant factor. The company needed a QMS that was affordable and suitable for all their key teams: Executive, Quality, and Product Development.
The Solution
MTI chose to partner with Greenlight Guru, a provider of an affordable, robust QMS solution tailored for MedTech companies. The decision was influenced by Greenlight Guru’s proven track record of assisting over 1000 MedTech companies at various stages of scaling. Greenlight Guru’s eQMS and Strategic Guru Services were instrumental in helping MTI navigate multiple audits. The solution also provided valuable resources such as SOP Templates and Greenlight Guru Academy courses, which served as training and education for new hires. As MTI continues to grow and develop new diagnostic and treatment solutions, they plan to use Greenlight Guru’s Design Control and Risk Management to document their work and achieve their product goals.
Operational Impact
Quantitative Benefit
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