Marco Delbo, MSc.
Marco is an experienced consultant and lead auditor in the medical device area. As an auditor, Marco is a lead auditor for BSI, one of the largest Notified Bodies worldwide, where he is qualified for CE marking, ISO 13485, CMDCAS and Microbiological assessments. Prior to BSI, he was a qualified auditor for a number of other Notified Bodies, including MDC and CertiQuality. He was also Inspector (Team Leader) for the Italian Competent Authority (Ministry of Health), for surveillance of manufacturers of Medical Devices.
As a consultant, Marco developed extensive and international experience in assisting companies in projects for CE marking of a large range of medical devices from class I to class III mostly in the non-active device area (disposables, sutures, implants including devices incorporating animal tissues, borderline and combination products), including Risk Management, fulfillment of Essential Requirements, preparation of Technical Files and ISO 13485 certification.
He is an expert in European Regulations based on 25 years hands-on working in the field, as a product reviewer, regulatory specialist, and senior manager. He combines strong experience in quality, compliance, and regulations with a pragmatic, result driven approach at both operational and exec level. Working for the Italian Standards Institute and attending CEN and ISO meetings, he developed also extensive knowledge of standards in the medical device area. Based on his Master’s degree in Microbiology, he has competence in the Sterilization and Biocompatibility fields.
Marco is native Italian, speaks fluent English and can understand French and Spanish.