Case Study: a leading software as a medical device company improves efficiency and cuts costs with Greenlight Guru eQMS

Scaling SaMD Company Upgrades from Paper to Increase Efficiency While Reducing Costs

A leading medical device company working as a software as a medical device (SaMD) organization needed a QMS that could keep up with its digital health products. Greenlight Guru was brought in after the company found its paper-based QMS inefficient, difficult to manage for employee training, costly to store, and prone to audit findings.

Greenlight Guru’s eQMS solution replaced the manual system with a fully traceable, pre-validated platform for document control, training tracking, and audit preparation. The company saved the equivalent of one full-time employee’s salary, cut QMS setup time by 60–70%, reduced audit prep time by about 30%, and saw fewer findings and follow-up items, while also eliminating paper storage costs.