Consulting firm specializing
in the medical device sector
Partnering with you to ensure your project
meets the highest standards for success.
Consulting firm specializing
About us
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.
Before establishing his own companies, Giacomo worked as a consultant within leading firms in the field of quality systems and process reengineering, and previously held operational roles in logistics planning within multinational groups in the Health & Beauty Care and Horeca sectors.
He has conducted first- and second-party audits and is trained as an ISO 13485 Auditor, Person Responsible for Regulatory Compliance (PRRC) under MDR/IVDR, and in all major product and process standards relevant to the medical device sector
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, supporting manufacturers, distributors, and clinical facilities with an approach rooted in technical accuracy, regulatory responsibility, and long-term value creation.
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 a wide range of standards and regulatory frameworks, including ISO 13485, ISO 9001, ISO 14971, GMP, IFS HPC, BRC, and the preparation of technical documentation and CE marking for medical devices 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 his professional activity as an independent consultant, supporting manufacturers with the development, maintenance, and regulatory upgrade of technical documentation, quality systems, and post-market surveillance processes. His in-depth experience also includes internal audits, supplier audits, and process reengineering activities aimed at improving operational efficiency and compliance.
Over the course of his career, he has collaborated with companies of all sizes—from innovative start-ups to established industrial groups—developing a practical and results-oriented approach grounded in technical competence, regulatory rigor, and clear communication.
Today, Fabrizio supports national and international clients across diverse sectors of the medical device supply chain, offering high-level consulting for quality management, regulatory strategy, CE marking compliance, internal process design, and continuous improvement, contributing to the safe and effective introduction of medical technologies into the market.
OUR GOAL IS YOUR SUCCESS
Why choose Altrion?
Personalized advice tailored to your needs
ALTRION was founded through the collaboration of a group of consultants and professionals with over 15 years of experience in the medical device industry, who decided to unite their expertise under one international brand.
The goal of ALTRION is to provide comprehensive and integrated regulatory solutions for the global placement of medical devices and in vitro diagnostics, supporting manufacturers, importers, and distributors throughout the entire product life cycle — from design to post-market surveillance.
With a network of partner or proprietary offices located across Europe, the United Kingdom, Switzerland, the United States, and Canada, ALTRION serves as a reliable partner for companies seeking local regulatory representation and tailored strategic consulting.
Our approach combines regulatory precision, transparency, and operational flexibility, offering clients a single point of contact capable of managing compliance with all major international frameworks: MDR/IVDR, MedDO, UK MDR 2002, and FDA 21 CFR.
ALTRION is not just a technical consultant — it is a strategic partner, committed to supporting the growth and long-term sustainability of companies in the global medical device market.
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