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.
Latest Articles
Blog & Insights
ISO 10993-1:2025 From Checkbox Compliance to Risk-Based Biocompatibility
Last Updated: 2026-08-10
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Blog & Insights
EU MDR 2017/745 for Dental Devices: Complete Guide (2026)
A practical EU MDR 2017/745 guide for dental device manufacturers. Learn how to classify products, align clinical evidence…
Last Updated: 2026-07-15
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Blog & Insights
MDR Annex XVI: Regulating Products Without an Intended Medical Purpose Under the MDR
Guide for manufacturers seeking EU market access, explaining scope, classification, and compliance requirements under MDR Annex XVI.
Last Updated: 2026-07-23
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Case studies
Case Study: How MDx Enabled Argen’s Successful Transition to MDR CE Marking for Dental Alloys
Last Updated: 2026-07-15
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Regulatory Updates
Blog & Insights
Blog & Insights
ISO 13485 Implementation Guide for Medical Device and IVD Companies
Last Updated: 2026-07-24
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Blog & Insights