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Master in
Quality, Regulatory, Clinical & Medical Affairs in Medical Devices & In Vitro Diagnostics

1st Edition

Syllabus Unfold syllabus

  • Introduction to Medical Devices and In Vitro Diagnostics
    3 ECTS

    The goal of this subject is to discuss the general aspects of the development and commercialisation of Medical and In Vitro Diagnostic Devices. Specifically, it will focus on the following topics:

    • From scientific discovery to product concept
    • Innovative concepts vs. Innovative workflows?
    • Market surveys - unmet needs - advisory boards
    • Quality, regulatory and clinical strategies
    • Regulation as a guardrail or as a limitation?
    • Spin-offs and start-ups
  • Intended Uses and Types of Medical Devices and In Vitro Diagnostic Devices
    3 ECTS

    The objective of this subject is to provide insights into:

    • Intended use - connection to the new product concept
    • Types of Medical Devices:
      • Sterile, implantable, invasive, etc.
      • Software
      • Systems: instrument, software and reagents
    • Types of In Vitro Diagnostic Devices:
      • Infectious diseases
      • Oncology
      • Companion diagnostics
      • Point of care
      • Home use
  • Quality Assurance and Quality Management Systems
    6 ECTS

    The Principles of Quality Management - Quality Assurance

    • The ISO 13485, the quality standard for MD and IVD organisations, and the foundation of the Quality Management System (QMS) requirements.
    • Product Risk Management: a central concept in MD and IVD development
    • Other applicable norms. Case examples of specific MDs and IVDDs: different types (software) and risk classifications
    • Change control and CAPA?
    • Supplier Quality Assurance
    • Audits and Auditing
  • Design Control
    6 ECTS

    Design Control and its phases: Feasibility and Development, Verification, Validation, Transfer, Launch

    • Traceability Matrix: definition of user needs, requirements, specifications
    • Design Change Management + Post-Market Surveillance (PMS)
    • Design History File (DHF) index, processes and dependencies
  • Regulations - Europe
    6 ECTS

    The goal of this subject is to provide insights into:

    • The need for a regulatory framework for Medical Devices and In Vitro Diagnostic Devices
    • Regulatory strategy as a key element for the success of an MD and IVDD - constraints and opportunities
    • European framework of regulations
      • EU 2017/745 Medical Device Regulation (MDR)
      • EU 2017/1746 In Vitro Diagnostics Regulation (IVDR)
  • Regulations - Rest of the World
    6 ECTS
    • The American Framework: 510 (k) C8PMA and DeNovo processes
    • Other countries: Australia, Canada, Brazil, Japan and China
    • Medical Device Single Audit Program (MDSAP)
    • Vigilance and regulatory aspects of post-market surveillance
  • Clinical Performance Evaluation
    6 ECTS

    The goal of this subject is to provide insights into:

    • The Clinical Performance of MDs and IVDDs: strategy is key for product success
    • Documentation of the Clinical Evaluation:
      • Scientific Validity
      • Appraisal
      • Analysis of the verification and validation data
      • General Safety and Performance Requirements (GSPR) and PMS plan
    • Clinical evaluations under FDA
  • Clinical Studies
    6 ECTS
    • Clinical processes - and ISO 15989
    • Clinical study phases
    • Documentation: the clinical file - basic structure
    • Data management and data analysis
    • Clinical research organisations
  • Medical Affairs in the Post-Launch Stage
    6 ECTS

    The goal of this subject is to discuss general aspects related to:

    • Post Market Performance Follow-up (PMPF)
    • Investigator-initiated studies and other types of post-launch collaborations
    • Health Economics and Outcome studies
    • Medical Affairs vs. sales and marketing
    • Introduction to compliance - Sunshine Act and other regulations
  • End-of-Master Project
    6 ECTS

    The End-of-Master Project is recommended as the most comprehensive strategy for embarking on the development and commercialisation of a MD or an IVDD. Group projects are admitted.

Qualification

Lifelong Learning Master’s Degree in Quality, Regulatory, Clinical & Medical Affairs in Medical Devices & In Vitro Diagnostics by the University of Girona.*

*Pending approval by the University of Girona.
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