ISO TC 157 Expert Member, Quality & Regulatory Management, Pasante Healthcare
MSc Jorge Figueira is an expert member of the ISO TC/157 Committee and the BSI CH/157 Committee. He has over 16 years experience in QA/QC/RA working with medical devices, In-vitro diagnostic devices, cosmetics, construction, software, low voltage equipment, personal protective equipment, food products, household products, chemicals and toiletries. He has experience as Lead Auditor recognised by IRCA and BSI, and working and auditing experience in countries such as Portugal, Spain, Malaysia, China, Thailand, Netherlands, Luxembourg, Czech Republic, Colombia, Venezuela and the United Kingdom. He is a subject matter expert in maintaining Technical Files and working on a quality, regulatory and technical level with medical devices from class I to class III under the MDD, and class B and C in-vitro diagnostic devices under the current IVD. In his current role, he is working on the implementation of the UDI related to manufacturers, distributors and importers of medical devices and in-vitro diagnostic devices in the EU.