Case Study: Lucerno Dynamics cuts ISO 13485 audit prep from weeks to hours with Greenlight Guru

Lucerno Dynamics cuts ISO 13485 audit prep from weeks to hours with Greenlight Guru

Lucerno Dynamics, a medical device company, faced challenges preparing for ISO 13485:2016 certification with a disorganized "paperless paper" system based in Dropbox. This system lacked the necessary validation for FDA and ISO requirements and could not scale with their planned international growth. They needed a proper electronic quality management system (eQMS) and chose to implement Greenlight Guru's medical device QMS software.

By implementing Greenlight Guru, Lucerno Dynamics streamlined its audit preparation process. The vendor's solution provided easy validation and integrated document control. The result was a dramatic reduction in audit prep time, from what previously took weeks down to just a few hours, enabling a successful internal audit and smooth path to certification. Greenlight Guru provided a scalable, validated QMS that met all regulatory requirements.

Lucerno Dynamics