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Class Medical Devices

  • Presentation

    Presentation

    The medical device sector is of high technical-scientific and regulatory complexity.

    Its use is increasingly frequent, encompassing a wide range of products that have come to assume a key role in the health system, with high economic value.

    The UC of medical devices will cover the technical - regulatory and technical - scientific aspects of the life cycle of the medical device, from concept to market, which support the guarantee of its safe use and the defense of public health.

    Through practical cases will be developed the ability to analyze, interpret knowledge and facts with application in problem solving.

  • Code

    Code

    ULHT2629-4626
  • Syllabus

    Syllabus

    • Regulation of Health Technologies and Medical Devices: Regulatory Framework; Research and Development, Technical-Scientific Assessment; Risk classes and border demarcation; Essential pre and post market requirements; European Standards and CSs; Pre-clinical, clinical /Clinical and functional performance investigation; Technical documentation; Pre- and post-market Conformity Assessment: and Procedures;
    • Health economics in medical devices: Surveillance, Post-marketing monitoring and market surveillance; Registration of medical devices, Coding, Traceability and Unique Identification of medical devices; Economic Evaluation and SINATS.
    • Market access: Acquisition of medical devices by the NHS; Transparency and access to information about medical devices.
  • Objectives

    Objectives

    It aims to provide appropriate training in medical devices to students of the Master of Health Products and Food Supplements, from conception to market access, including regulatory aspects and scientific technical aspects, enabling them to perform related activities. medical devices, namely in the Industry Sector, the National Health Service, the Community Pharmacy and the Regulatory Authorities

  • Teaching methodologies and assessment

    Teaching methodologies and assessment

    Apresentação de casos pelos alunos, mediante orientação do docente e posterior discussão por todos os alunos 

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