Our story

 NOEI is founded by Bolette Nordby in 2025.

With 25 years of experience in the Medical Device and Combination Product industry, I support organizations in designing and strengthening their Quality Management Systems, improving compliance, and building sustainable quality cultures. My approach is hands‑on, pragmatic, and tailored to each organization’s maturity, structure, and product complexity. Also I worked 3 years as a Lead Auditor at a Notified Body and has since 2023 been trainer at the MedTech Denmark course ‘ISO 13485 and Quality Management for Medical Devices / Auditing’.

Bolette holds a master’s degree from Technical University of Denmark (DTU)