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      Department of Biomedical Engineering

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      BME 436 | Course Introduction and Application Information

      Course Name
      Medical Device Policies and Regulations
      Code
      Semester
      Theory
      (hour/week)
      Application/Lab
      (hour/week)
      Local Credits
      ECTS
      BME 436
      Fall/Spring
      3
      0
      3
      5

      Prerequisites
      None
      Course Language
      English
      Course Type
      Elective
      Course Level
      First Cycle
      Mode of Delivery -
      Teaching Methods and Techniques of the Course -
      National Occupation Classification -
      Course Coordinator
      • Dr. Öğr. Üyesi Yalın Kılıç
      Course Lecturer(s)
      • Dr. Öğr. Üyesi Yalın Kılıç
      Assistant(s) -
      Course Objectives The aim of this course is to give an introduction to policies for medical devices in health plan and mandatory regulations for medical device manufacturers.
      Learning Outcomes
      #
      Content
      PC Sub
      * Contribution Level
      1
      2
      3
      4
      5
      1Define medical devices,
      2Classify medical devices,
      3Describe medical device labels and the Unique Device Identifier System,
      4Evaluate CE Technical Dossier,
      5Discuss the position of medical devices in health policies of Turkey and globally,
      6Define priorities in medical device innovation.
      Course Description The course covers recommendations of World Health Organization, framework policies and resolutions and regulations about medical devices in Turkey and globally; also the principles of Medical Device Directive, quality management system for medical devices and similar legal regulations and directives for medical device manufacturers and importers.
      Related Sustainable Development Goals

       



      Course Category

      Core Courses
      Major Area Courses
      X
      Supportive Courses
      Media and Management Skills Courses
      Transferable Skill Courses

       

      WEEKLY SUBJECTS AND RELATED PREPARATION STUDIES

      Week Subjects Related Preparation Learning Outcome
      1 Introduction to BME 4xx Lecture
      2 Definition of Medical Devices Development of medical device policies, WHO Medical device technical series
      3 Policies and Resolutions on Medical Devices Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ , Global Harmonization Task Force
      4 Quality and Safety Regulations for Medical Devices Regulation of medical devices: A step-by-step guide, WHO Regional Publications, Eastern Mediterranean Series
      5 Medical Device Directives and Medical Device Regulations Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union
      6 In Vitro Diagnostic Device Regulations Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Official Journal of the European Union
      7 Quality Management System for Manufacturing Medical Devices Edward P Link. An Audit of the System, not of the People - An ISO 13485:2016 Pocket Guide for Every Employee
      8 Technical Dossier for CE Marking Guidance Technical Documentation and Design Dossiers for Non Active Medical Devices, TÜV Süd Product Service GmbH
      9 Standards in Instructions for Use and Patient Manuals EU MDR, Chapter III, 23.1
      10 Review and Mid-term Exam
      11 Health Technology Assessment and Management 2015 Global Survey on Health Technology Assessment by National Authorities. Main findings. I. World Health Organization.
      12 Priority Medical Devices Medical devices: Managing the Mismatch An outcome of the Priority Medical Devices project . World Health Organization
      13 Target Product Profiles in Medical Device Innovation A Multiplex Multi-Analyte Diagnostic Platform, Medecins Sans Frontieres
      14 Global Atlas of Medical Devices and Policies of Turkey Global Atlas of medical devices, WHO medical devices technical series
      15 Review
      16 Final Exam

       

      Course Notes/Textbooks

      European Medical Device Regulation (MDR) for MedTech and Medical Device Manufacturers, Mr Des O'Brien 

      ISBN: 978-1092813518

      Suggested Readings/Materials

       

      EVALUATION SYSTEM

      Semester Activities Number Weigthing LO 1 LO 2 LO 3 LO 4 LO 5 LO 6
      Participation
      Laboratory / Application
      Field Work
      Quizzes / Studio Critiques
      Portfolio
      Homework / Assignments
      Presentation / Jury
      Project
      1
      50
      Seminar / Workshop
      Oral Exams
      Midterm
      1
      20
      Final Exam
      1
      30
      Total

      Weighting of Semester Activities on the Final Grade
      2
      70
      Weighting of End-of-Semester Activities on the Final Grade
      1
      30
      Total

      ECTS / WORKLOAD TABLE

      Semester Activities Number Duration (Hours) Workload
      Theoretical Course Hours
      (Including exam week: 16 x total hours)
      16
      3
      48
      Laboratory / Application Hours
      (Including exam week: '.16.' x total hours)
      16
      0
      Study Hours Out of Class
      0
      Field Work
      0
      Quizzes / Studio Critiques
      0
      Portfolio
      0
      Homework / Assignments
      0
      Presentation / Jury
      0
      Project
      1
      60
      60
      Seminar / Workshop
      0
      Oral Exam
      0
      Midterms
      1
      18
      18
      Final Exam
      1
      22
      22
          Total
      148

       

      COURSE LEARNING OUTCOMES AND PROGRAM QUALIFICATIONS RELATIONSHIP

      #
      PC Sub Program Competencies/Outcomes
      * Contribution Level
      1
      2
      3
      4
      5
      1

      To have adequate knowledge in Mathematics, Science and Biomedical Engineering; to be able to use theoretical and applied information in these areas on complex engineering problems.

      -
      -
      -
      -
      -
      2

      To be able to identify, define, formulate, and solve complex Biomedical Engineering problems; to be able to select and apply proper analysis and modeling methods for this purpose.

      -
      -
      -
      -
      -
      3

      To be able to design a complex system, process, device or product under realistic constraints and conditions, in such a way as to meet the requirements; to be able to apply modern design methods for this purpose.

      -
      -
      -
      -
      X
      4

      To be able to devise, select, and use modern techniques and tools needed for analysis and solution of complex problems in Biomedical Engineering applications.

      -
      -
      -
      -
      -
      5

      To be able to design and conduct experiments, gather data, analyze and interpret results for investigating complex engineering problems or Biomedical Engineering research topics.

      -
      -
      X
      -
      -
      6

      To be able to work efficiently in Biomedical Engineering disciplinary and multi-disciplinary teams; to be able to work individually.

      -
      X
      -
      -
      -
      7

      To be able to communicate effectively in Turkish, both orally and in writing; to be able to author and comprehend written reports, to be able to prepare design and implementation reports, to present effectively, to be able to give and receive clear and comprehensible instructions.

      -
      -
      -
      -
      -
      8

      To have knowledge about global and social impact of Biomedical Engineering practices on health, environment, and safety; to have knowledge about contemporary issues as they pertain to engineering; to be aware of the legal ramifications of engineering solutions.

      X
      -
      -
      -
      -
      9

      To be aware of ethical behavior, professional and ethical responsibility; to have knowledge about standards utilized in engineering applications.

      -
      -
      -
      -
      -
      10

      To have knowledge about industrial practices such as project management, risk management, and change management; to have awareness of entrepreneurship and innovation; to have knowledge about sustainable development.

      X
      -
      -
      -
      -
      11

      To be able to collect data in the area of Biomedical Engineering, and to be able to communicate with colleagues in a foreign language.

      -
      -
      -
      -
      -
      12

      To be able to speak a second foreign language at a medium level of fluency efficiently.

      -
      -
      -
      -
      -
      13

      To recognize the need for lifelong learning; to be able to access information, to be able to stay current with developments in science and technology; to be able to relate the knowledge accumulated throughout the human history to Biomedical Engineering.

      X
      -
      -
      -
      -

      *1 Lowest, 2 Low, 3 Average, 4 High, 5 Highest


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