Consulting firm specializing in the medical device sector
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Experts working on your project
Eng. Giacomo Cornara and Eng. Fabrizio Cavagnoli lead Altrion, a consulting firm specialised in the medical device sector. Building on years of experience gained in the medical devices field—both within structured organisations and as independent professionals—they have developed a comprehensive understanding of the various consulting approaches and the specific needs of companies operating in this highly regulated industry.
This complementary set of skills has led to the growth of Altrion, a company that supports businesses of all sizes in achieving their regulatory compliance goals.
Giacomo Cornara
Senior consultant specialized in Regulatory Affairs, Quality Management Systems, and international Compliance for medical devices and IVDs, with more than 12 years of experience across European and global markets. He is the founder and director of MDQ Services Ltd, co-founder of Elite Med Group Sagl, and owner of MDQ di Giacomo Cornara SAS, organizations operating in the fields of CE marking, UKCA marking, FDA and Health Canada regulatory pathways, as well as EU REP, CH-REP, and UKRP representative services for medical device manufacturers. Throughout his career, he has supported numerous manufacturers in developing technical documentation in compliance with the Regulation (EU) 2017/745 and major international standards, managing projects involving active devices, non-active devices, and stand-alone or embedded software. His expertise spans the full regulatory spectrum: ISO 13485, ISO 14971, IEC 60601-1 / 60601-1-2, IEC 62304, IEC 62366, sterilization (ISO 11135), biocompatibility (ISO 10993-1), LVD/EMC, RED, MDSAP, FDA 510(k), and Health Canada licensing. He holds a Degree in Management Engineering from Politecnico di Milano and continues to invest in advanced professional development through institutions such as BSI, IMQ, TÜV, Kiwa, and Confindustria Dispositivi Medici. Today, he leads international teams and projects for the introduction, certification, and ongoing compliance of medical devices across major global markets.
Fabrizio Cavagnoli
Senior specialist in Quality Management Systems, Regulatory Affairs, and Compliance for medical devices and related industries, with nearly 28 years of experience supporting manufacturers, importers, and distributors in achieving and maintaining conformity on European and international markets. For over 20 years, he worked within IPQ Tecnologie Srl, one of Italy's most established consulting firms in quality systems and regulatory compliance, where he played a key role in assisting companies with the implementation, optimization, and certification of management systems. His experience covers ISO 13485, ISO 9001, ISO 14971, GMP, IFS HPC, BRC, and the preparation of technical documentation and CE marking under the former Directives (93/42/EEC, 98/79/EC) and the current Regulations MDR (EU) 2017/745 and IVDR (EU) 2017/746. Since 2023, Fabrizio has continued as an independent consultant. Over his career he has collaborated with companies of all sizes—from innovative start-ups to established industrial groups—developing a practical, results-oriented approach grounded in technical competence, regulatory rigor, and clear communication.
Yunji Yim
International Business professional specialized in cross-border coordination and market entry support, with a focus on bridging Korean manufacturers with European and global regulatory services. She plays a key role in facilitating communication and alignment between Korean clients and international regulatory teams, ensuring that complex compliance requirements are clearly understood and efficiently managed across different cultural and business environments. Yunji supports Korean medical device and IVD manufacturers throughout their expansion journey, assisting in project coordination, documentation flow, and communication with European and global partners involved in CE marking, UKCA, and other international regulatory pathways. She holds a degree in International Business Management and has developed experience in international trade and project coordination, working in multicultural environments.