Mustafa Dinc
Senior Medical Device Quality & Regulatory Affairs Consultant
Mustafa Dinc has approximately 17 years of experience in the medical device industry. As a Quality Assurance and Regulatory Affairs (QA/RA) consultant, he supports international medical device manufacturers and distributors in implementing regulatory requirements, developing and optimising quality management systems, preparing for and supporting audits, and ensuring regulatory readiness for market launch.
His professional background combines a strong technical foundation in mechanical engineering with an MBA in Compliance & Risk Management.
Mustafa’s experience includes developing and improving quality management systems in accordance with ISO 13485, implementing EU MDR requirements, reviewing and remediating technical documentation, addressing audit findings, establishing post-market surveillance and vigilance processes, and supporting international medical device registrations and regulatory approvals.
His core competencies include EU MDR, ISO 13485, MDSAP, FDA Part 820, Swiss medical device regulatory affairs, Quality Management Systems (QMS), risk management according to ISO 14971, Post-Market Surveillance (PMS), vigilance, Corrective and Preventive Actions (CAPA), audit preparation, validation and process validation.
Mustafa is passionate about transforming complex regulatory requirements into clear, practical and sustainable quality processes. Patient safety, regulatory compliance and continuous process improvement are at the heart of his work.
