Henry B

EU MDR & CE Marking Regulatory Consultant

MedTech Corporation

Jan 2023 - Present • 3 yrs 4 mos

Provided regulatory consulting and compliance support for medical device manufacturers seeking market access under EU MDR requirements. Assisted clients with CE marking strategies, ISO 13485 quality management systems, technical documentation preparation, risk management implementation, and post-market compliance activities. Key responsibilities included: • Development and review of EU MDR technical files and regulatory documentation • Support for CE marking pathway selection and conformity assessment planning • Preparation of EUDAMED documentation and registration guidance • Gap analysis against EU MDR and ISO 13485 standards • Quality Management System (QMS) implementation and maintenance support • Risk management documentation aligned with ISO 14971 principles • Clinical evaluation and compliance strategy assistance • Audit readiness preparation and internal compliance reviews • Regulatory pathway consulting for Class I, IIa, IIb, and III medical devices • Coordination support for EU Representative documentation requirements Successfully helped manufacturers improve compliance readiness, reduce approval delays, and streamline certification processes for European market entry.