Giacomo CargnelloHead of Quality & Regulatory, Connect&Control Solutions at Varex Imaging
Giacomo Cargnello is currently the Global Quality&Regulatory 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 20+ 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 10+ working experience in the Medical Device Industry (Varex, Philips, Baxter, St. Jude Medical/Abbott) covering different medical equipment (implantable pacemaker and defibrillator, hemodialysis equipment, image-guided therapy system, imaging devices for Diagnosis (MR, DXR, CT, PET scans) and medical software products) and covering different QA&RA roles with experience in leadership, quality management and regulatory approval of medical devices, project management and development.
Giacomo Cargnello is an expert on International Regulations and Standards (certified (Lead) Auditor) and especially EU MDR, ISO 13485, ISO 9001, FDA QSReg, Canadian MDR (SOR-98-282), jPMD Act, IEC 60601, ISO 14971, ISO 62304.
He holds a Master’s Degree in Biomedical Engineering (MSc/MEng) and he participated in several International Q&R conferences as a speaker.
Addressing Challenges with Labelling and UDI Requirements, 16:35View Session
Industry Panel: Preparing Quality Management Systems Prior to Notified Body Audits, 14:00View Session