Greenlight Guru Case Studies Monitored Therapeutics, Inc: Streamlining Regulatory Compliance with Greenlight Guru

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	Monitored Therapeutics, Inc: Streamlining Regulatory Compliance with Greenlight Guru Greenlight Guru

Monitored Therapeutics, Inc: Streamlining Regulatory Compliance with Greenlight Guru

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

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

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.

About 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.

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.

Impact #1	The implementation of Greenlight Guru’s eQMS has significantly improved MTI's ability to manage its commercialized products globally and maintain the company’s quality as it grows. The system has successfully guided MTI through six audits in a year, demonstrating its effectiveness in navigating complex regulatory landscapes. The company has also been able to scale its office space by 7x and double its headcount, indicating robust growth. The addition of Guru Strategic Services has provided valuable support to the team, with a dedicated consultant available for any industry or specific needs-related questions. The Greenlight Guru Academy courses and certification tracks have also served as a valuable resource for training and educating new hires.

Impact #1

The implementation of Greenlight Guru’s eQMS has significantly improved MTI's ability to manage its commercialized products globally and maintain the company’s quality as it grows. The system has successfully guided MTI through six audits in a year, demonstrating its effectiveness in navigating complex regulatory landscapes. The company has also been able to scale its office space by 7x and double its headcount, indicating robust growth. The addition of Guru Strategic Services has provided valuable support to the team, with a dedicated consultant available for any industry or specific needs-related questions. The Greenlight Guru Academy courses and certification tracks have also served as a valuable resource for training and educating new hires.

Benefit #1	Successfully navigated 6 audits over the course of a year
Benefit #2	Scaled office by 7x
Benefit #3	Doubled the company’s headcount

Benefit #1

Successfully navigated 6 audits over the course of a year

Benefit #2

Scaled office by 7x

Benefit #3

Doubled the company’s headcount

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Overview

Monitored Therapeutics, Inc: Streamlining Regulatory Compliance with Greenlight Guru

Operational Impact

Quantitative Benefit