Case Study: Lucerno Dynamics achieves simplified ISO 13485:2016 certification with Greenlight Guru

Lucerno Dynamics has Simplified the ISO 13485:2016 Certification Process with Greenlight Guru

Lucerno Dynamics, a Cary, North Carolina maker of Class I devices sold in the US, Australia and New Zealand, needed to achieve ISO 13485:2016 certification but was hampered by a “paperless paper” Dropbox system that couldn’t be validated to meet FDA 21 CFR Part 11, lacked integrated document control, and couldn’t scale for international expansion. To address these gaps they selected Greenlight Guru’s eQMS, drawn by its Design Control and Risk Management capabilities.

Greenlight Guru implemented a right-sized eQMS that ties product development to post-market quality and enables easy validation; Lucerno migrated and validated their records with Greenlight Guru in just over a week and a half, passed a successful internal audit with auditors praising end-to-end traceability, and reduced audit preparation to only a few hours. The Greenlight Guru solution gave Lucerno a scalable, validated QMS that supports ISO 13485:2016 and FDA requirements and improved their overall quality culture.

Lucerno Dynamics

Tonia Bryant

Director of Quality and Regulatory Affairs