Director
CurrentExperienceConsultancy for the application of the requirements of the Medical Devices MDR and IVDR for manufacturers of these devices established within Spanish territory. Hands-on tasks include: - Classification of medical devices - Format and preparation of Technical Documentation for conformity assessment. - Determination of standards applicable to particular medical devices and establishment of test protocols in accordance with these standards. - Clinical evaluation of medical devices acc MDR/IVDR & MEDDEV 2.7.1 - Risk management plans and periodic reports in accordance with EN ISO 14971:2019Consultancy for the establishment and implementation of Quality Management Systems for certification to standards EN ISO 13485 and compliance with QSR GMP (21CFR820). Hands-on tasks include: - Development of quality policies, manuals and objectives. - Development of process maps, diagrams and indicators. - Development of procedures, work instructions and test methods. - Follow-up monitoring of system implementation through internal audits.Consultancy for the validation of special and/or automated processes used in the manufacture of medical devices. Hands-on tasks include: - Establishment of process specifications including URS for software-controlled processes. - Development of validation plans and protocols. - Assessment of test methods used to implement validation protocols and review of the results
