Giacomo Cargnello

Head of Quality & Regulatory, Connect&Control Solutions at Varex Imaging

Advisor

Giacomo Cargnello is currently the Global Quality Assurance and Regulatory Affairs Head of the Business Group Connect&Control Solutions, part of Varex Imaging Corporation, a world leader in X-Ray imaging components and medical devices such as tubes, generators, high-voltage connectors, collimators, etc...

He is leading a multi-disciplinary team of QA/RA managers and specialists across 4 different sites (The Netherlands, Philippines, China and USA) and he is also a member of the Business Group Management Team.

He holds diversified working experience in the Medical Device Industry in several companies (Varex, Philips, Baxter, St. Jude Medical/Abbott) and covering different medical and industrial equipment, such as implantable pacemaker and defibrillator, hemodialysis equipment, Imaging Devices and Components (MR, DXR, CT, PET scans) and medical software products. He covered different QA/RA roles with experience in leadership and transformation, quality management and regulatory approval, project management and design & development.

Giacomo Cargnello is an expert on International Regulations and Standards, both medical and industrial, such as EU MDR/MDD, ISO 13485, ISO 9001, FDA QSReg, Canadian SOR-98-282, jPMD Act, IEC 60601, ISO 14971, ISO 62304, LVD/EMC/RED/RoHS/REACH.

He holds a Master’s Degree in Biomedical Engineering (MSc/MEng) and he participated in several International QA/RA conferences as a speaker, panelist and moderator.