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IPLUSO 19581

Medical Devices and Health Products

Pharmacy
  • ApresentaçãoPresentation
    The medical devices course will cover the technical - regulatory and technical - scientific aspects involved in the entire life cycle of medical devices, which support the guarantee of their safe use and the defense of public health. Through practical cases, the capacity for analysis and interpretation of knowledge will be developed. and facts with application in problem solving.
  • ProgramaProgramme
    Scope and regulatory frame of medical devices Definitions, risk classification and borderline demarcation Essential requirements related with safety, quality and performance Standardization and conformity with the essential requirements Risk Management Plane Clinical evaluation/clinical investigation Conformity assessment Placing on the market/ Regulatory requirements Vigilance system Supermarket surveillance Requirements for the acquisition of medical devices by the purchasing departments The role and the meaning of the different players in the regulatory system of medical device and in the safety and health protection of patients and users.
  • ObjectivosObjectives
    Know how to interpret and apply technical-normative and technical-scientific requirements in all phases of the life cycle of medical devices, from design to market. Understand the role and activities to be developed by the different entities involved
  • BibliografiaBibliography
    Parlamento Europeu e do Conselho. Regulamento (UE) 2017/745 do Parlamento Europeu e do Conselho de 5 de abril de 2017. J Oficial Comunidades Europeias L 117 (5.5.2017), 1¿175 Parlamento Europeu e do Conselho. Regulamento (UE) 2017/746 do Parlamento Europeu e do Conselho, de 5 de abril de 2017. J Oficial Comunidades Europeias. L 117 (5.5.2017), 176¿ 332 https://ec.europa.eu/health/md_sector/overview_en https://www.infarmed.pt/web/infarmed/entidades/dispositivos-medicos  
  • MetodologiaMethodology
    In this curricular unit, the Team-based learning (TBL) methodology is used, with tasks carried out in small groups, allowing the development of the ability to analyze and apply theoretical concepts.  
  • LínguaLanguage
    Português
  • TipoType
    Semestral
  • ECTS
    4
  • NaturezaNature
    Mandatory
  • EstágioInternship
    Não