Alejandro Ferreiro Morales

Auditing of quality management systems of medical device manufacturers according ISO 13485, MDSAP, MDR, and UK MDR. Assessment of TD for low-risk medical under MDR, including expert assessment for Clinical Evaluation, Cybersecurity, and AI. Internal auditor to ensure compliance with MDR and EN ISO 17021-1 requirements for the Notified Body/Certification Body. Client management, including planning, preparation, and post-processing activities related to the conformity assessment procedure.

- Roles of QMR and PRRC - Implementation of a QMS according to ISO 13485 - Implementation of a ISMS according to ISO/IEC 27001 - Certification of a Software as Medical Device class IIa - Management of Technical Documentation - Internal audits of the different company processes - Management of CAPAs and non-conformities - Post-market surveillance and vigilance activities for medical devices

Regulatory affairs: Certification of medical devices (CE-marking, class IIa and IIb), MDD-MDR transition, Post-Market surveillance of medical devices. Registration of medical devices with different Health Authorities. Quality assurance: Maintenance of the Quality Management System following ISO13485, solving of non-conformities after audits of the company. Intellectual property: Patentability analysis of inventions, risk assessment of infringement against patents of other companies, market analysis.