Experience

Tecno-med Ingenieros

• Spain
• Business Consulting and Services
• 1 - 100 Employee

• Director

  • Jul 1995 - Present

  Experience Consultancy 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 14971:2019 Consultancy 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 Show less



SEEIC Sociedad Española de Electromedicina e Ingenieria Clinica

• Martinez Campos 44 28010 Madrid Spain

• Vice President

  • Nov 2013 - Present

  Vicepresidente de la SEEIC elegido en asamblea general de 8 de Noviembre de 2013 Vicepresidente de la SEEIC elegido en asamblea general de 8 de Noviembre de 2013



AEFI

• Barcelona Area, Spain

• miembro vocalía Productos Sanitarios

  • Nov 2006 - Present

  AEFI Asociación Española de Farmaceúticos de la Industria http://www.aefi.org AEFI Asociación Española de Farmaceúticos de la Industria http://www.aefi.org