Tibor Zechmeister

Tibor Zechmeister is a regulatory affairs expert with an academic background in biomedical engineering. He is focusing on the European Medical Device Regulation and associated regulations, standards, and guidance documents from three perspectives. First, he has been in the medical device industry for 12 years and has founded and co-founded his own medical device companies that have certified devices in Europe and beyond. Second, he is an auditor for a European Notified Body and conducts multiple audits per year to check regulatory compliance. Third, he has consulted for over 30 companies in recent years regarding various challenges and questions about regulatory compliance for medical devices.