Roger Rutten

Roger Rutten has extensive experience in quality assurance and regulatory affairs, currently serving as Lead Assessor for ISO 13485/MDR at ISO 13485-MDR, where responsibilities include assessing medical device software and advising on regulatory compliance. Roger is also a member of the Medical Device Software Expert Platform at NEN, focusing on standardization in the medical device sector. Previous roles include organizational consultant and trainer at Management by Horses, and Managing Director at InTe Medical BV and Microtechnologics BV, where expertise in laser technology and surgical instrument tracking was developed. Educational qualifications encompass a range of certifications and degrees in management and engineering from various reputable institutions.