Mr. Harry van Vugt – Certification Manager, Regulatory Medical specialist and Project Manager - DEKRA Notified Body
Mr. Harry van Vugt has many years of experience (since 1990) in the field of regulatory affairs, quality and certification of medical products.
He is specialized on different topics, such as product testing based on IEC 60601- series safety testing, risk management EN ISO 14971, Clinical evaluations, Usability engineering, and software life cycle reviews; European Directives (EMC, low Voltage, MDD and AIMD); quality system standards (ISO 9001 and 13485), QMS process approach, CMDCAS sector program (Canada).
Mr. Harry van Vugt is a DEKRA Certification Manager, Regulatory Medical specialist and Project Manager. He is lead auditor for ISO 9000/13485/AIMD/MDD, and Design Dossier reviewer for AIMD and MDD.