Case Study: Monitored Therapeutics achieves audit-ready QMS success with Greenlight Guru

How Greenlight Guru is helping medical device company Monitored Therapeutics, Inc. pass audits, keep their products on the market, and train their quality team

Monitored Therapeutics, Inc. (MTI) is a remote patient monitoring medtech company focused on respiratory diseases and home diagnostic devices, including its Bluetooth spirometer GoSpiro. As the company expanded globally, it needed an affordable, medtech-specific quality management system to help it navigate FDA, ISO 13485, MDSAP, and customer audits while supporting product quality and post-market surveillance. Greenlight Guru provided the QMS platform and related services to meet those needs.

With Greenlight Guru’s eQMS, Strategic Guru Services, SOP templates, and training resources, MTI streamlined document control, change orders, nonconformance, CAPA, and audit management. The result was a successful year that included six audits—three customer audits, plus FDA, MDSAP, and ISO 13485 audits—and the ability to scale its business, including a 7x office expansion and headcount growth, while maintaining confidence in managing commercialized products globally.

Monitored Therapeutics

Arianne Hatfield

QA Specialist