Medical Devices
MDR
Alberto Bardaji de Qixano
Head of Medical Devices at MDx CRO and a Master of Engineering with nearly 20 years of international experience in medical device development, regulatory affairs, and technical leadership. An authorised MDR and ISO 13485 Quality Management System (QMS) Auditor, he has held senior roles across industry and notified bodies, specialising in Class IIb and III medical devices. Alberto's expertise spans product development, regulatory strategy, clinical evaluation, regulatory compliance, conformity assessment, and quality management, helping manufacturers demonstrate compliance, navigate complex global regulatory requirements, and bring innovative medical technologies to patients.