Guilherme Semedo Email & Phone Number

Full hands on: - Medical devices regulatory affairs – Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR)- Implementation of medical devices Quality Management Systems (QMS) according to ISO 13485- Risk Management process according to ISO 14971- State of the Art evaluations- Development of electronic Quality Management SystemsExperience:- Elaboration of more than 10 regulatory roadmaps for medical devices and IVD- Integral implementation of two ISO 13485 QMS and support to the implementation of other 4 - Involvement in five ISO 14971 Risk Management processes - Integral elaboration of 4 State of the Art Reports- Elaboration and revision of Technical Documentation - Preparation and management of a PT2030 project- Medical devices from class I, IIa e IIb and IVD from class A and DCo-author of two published systematic reviews on antibiotic prescription and eHealth. Current academic interest includes regulatory science, medical devices and artificial intelligence.Non-business interests include calysthenics, running, wandering, contemporary art, electric bass and lord of the rings.