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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
      3
      0
      3
      5

      Prerequisites None
      Course Language English
      Course Type ELECTIVE_COURSE
      Course Level First Cycle
      Mode of Delivery Face-To-Face
      Teaching Methods and Techniques of the Course Presentation
      Question/Answer
      National Occupational Classification Code -
      Course Coordinator -
      Course Lecturer(s)
      • Dr. Öğr. Üyesi Yalın Kılıç
      Assistant(s)
      • Dr. Öğr. Üyesi Yalın Kılıç
      Course Objectives The aim of this course is to introduce the role of medical devices in healthcare policies and the regulations that medical device manufacturers must comply with.
      Learning Outcomes The students who succeeded in this course;
      Name Description PC Sub * Contribution Level
      1 2 3 4 5
      LO1 will be able to define medical devices. 1.5 X
      LO2 will be able to discuss the role of medical devices within healthcare policies in the world and in Turkey. 6.1 X
      LO3 will be able to explain medical device labeling and the medical device classification system. 1.5 X
      LO4 will be able to evaluate different technical files. 6.1 X
      LO5 will be able to define priorities for innovation in medical devices. 6.1 X
      Course Description The course covers the World Health Organization's recommendations regarding medical devices for the world and Turkey, central government policies and decisions, the Medical Device Regulation that medical device manufacturers and importers must comply with, the Principles of the Quality Management System for Medical Devices, and similar legal regulations and directives.
      Related Sustainable Development Goals
      -

       



      Course Category

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

       

      WEEKLY SUBJECTS AND RELATED PREPARATION STUDIES

      Week Subjects Required Materials Learning Outcome
      1 Introduction Lecture Notes LO1
      2 Definition of Medical Devices Development of medical device policies, WHO Medical device technical series LO1
      3 Policies and Decisions Regarding Medical Devices Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’ , Global Harmonization Task Force LO2
      4 Legal Regulations on the Quality and Safety of Medical Devices Regulation of medical devices: A step-by-step guide, WHO Regional Publications, Eastern Mediterranean Series LO3
      5 Medical Device Regulations and the Medical Device Directive 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 LO2
      6 In Vitro Diagnostic Device Regulation 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 LO2
      7 Quality Management System for Medical Device Manufacturing Edward P Link. An Audit of the System, not of the People - An ISO 13485:2016 Pocket Guide for Every Employee LO3
      8 Midterm -
      9 Standards in User and Patient Manuals EU MDR, Chapter III, 23.1 LO4
      10 Technical File for CE Marking International Guidelines LO4
      11 Health Technology Assessment and Management 2015 Global Survey on Health Technology Assessment by National Authorities. Main findings. I. World Health Organization. LO4
      12 Priority Medical Devices Medical devices: Managing the Mismatch An outcome of the Priority Medical Devices project . World Health Organization LO5
      13 Target Product Profiles for Innovations in Medical Devices A Multiplex Multi-Analyte Diagnostic Platform, Medecins Sans Frontieres LO5
      14 Medical Devices Global Atlas and Turkey's Policies Global Atlas of medical devices, WHO medical devices technical series LO5
      15 Review of the semester -
      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 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
      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
      Edward P Link . An Audit of the System not of the People - An ISO 13485:2016 Pocket Guide for Every Employee Kindle Edition Quality Pursuit Inc. (20 Aug. 2017) ASIN: B074ZLSF6S
      Development of medical device policies WHO Medical device technical series

       

      EVALUATION SYSTEM

      Semester Activities Number Weighting LO1 LO2 LO3 LO4 LO5
      Project 1 50 X X X X X
      Midterm 1 20 X X X
      Final Exam 1 30 X X X X X
      Total 3 100

       

      ECTS / WORKLOAD TABLE

      Semester Activities Number Duration (Hours) Workload
      Participation - - -
      Theoretical Course Hours 16 3 48
      Laboratory / Application Hours - - -
      Study Hours Out of Class 14 2 28
      Field Work - - -
      Quizzes / Studio Critiques - - -
      Portfolio - - -
      Homework / Assignments - - -
      Presentation / Jury - - -
      Project 1 32 32
      Seminar / Workshop - - -
      Oral Exams - - -
      Midterms 1 18 18
      Final Exam 1 24 24
          Total 150

       

      COURSE LEARNING OUTCOMES AND PROGRAM QUALIFICATIONS RELATIONSHIP

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

      Engineering Knowledge: Knowledge of mathematics, science, basic engineering, computation, and related engineering discipline-specific topics; the ability to apply this knowledge to solve complex engineering problems.

      1

      Mathematics

      2

      Science

      3

      Basic Engineering

      4

      Computation

      5

      related engineering discipline-specific topics

      LO1 LO3
      6

      the ability to apply this knowledge to solve complex engineering problems.

      2

      Problem Analysis: Ability to identify, formulate and analyze complex engineering problems using basic knowledge of science, mathematics and engineering, and considering the UN Sustainable Development Goals relevant to the problem being addressed.

      3

      Engineering Design: The ability to devise creative solutions to complex engineering problems; the ability to design complex systems, processes, devices or products to meet current and future needs, considering realistic constraints and conditions.

      1

      Ability to design creative solutions to complex engineering problems.

      2

      Ability to design complex systems, processes, devices or products to meet current and future needs, considering realistic constraints and conditions.

      4

      Use of Techniques and Tools: Ability to select and use appropriate tectıniques, resources, and modern engineering and computing tools. including estimation and modeling. far the analysis and solution of complex engineering problems while recognizing their limitations.

      5

      Research and ınvestigation: Ability to use research methods ta investigate complex engineering problems, including literature research, designing and conducting experiments, collecting data, and analyzing and interpreting results.

      1

      Literature research far the study of complex engineering problems

      2

      Designing experiments

      3

      Ability to use research methods, including conducting experiments, collecting data. analyzing and interpreting results

      6

      Global lmpact of Engineering Practices: Knowledge of the impacts of engineering practices on s.ociety, health and safety. ttıe economy, sustainability and the environment \ıVlthin the context of the UN Sustainable Development GoaJs; awareness of the legal implications of engineering solutions.

      1

      Knowledge of ttıe impacts of engineering practices on society, health and safety, economy, su.stainability and the environment, within the context of the UN Sustainable Development Goals.

      LO2 LO4 LO5
      2

      Awareness of the legal implications of engineering solutions

      7

      Ethical Behavlor: Acting in accordance with the principles of the engineering profession. knowledge about ethical ,esponsibility; awareness of being impartial. without discrimination, and being inclusive of diversity.

      1

      Acting in accordance with engineering professional principles. information about ethical responsibility

      2

      Awareness of being impartial and indusive of diversity, without disaiminating on any subject.

      8

      lndividual and Teamwork: Ability to work effectively individually and as a team member or leader on interdis.ciplinary and multidisciplinary teams (face-to-face, remote or hybrid).

      1

      lndividually and within the discipline

      2

      Ability to work effectivefy as a team member or leader in mutti-disciplinary teams (face-to-face, remote or hybrid)

      9

      Verbal and Written Communication: Taking into account the various differences of the target audience (such as education, language, profession) on technical issues.

      1

      Verbal

      2

      Ability to communicate effectively in writing.

      10

      Project Management: Knowledge of business practices such as project management and economic feasibility analysis; awareness of entrepreneurship and innovation.

      1

      Knowledge of business practices such as project management and economic feasibility analysis;

      2

      Awareness of entrepreneurship and innovation.

      11

      Lifelong Learning: Lifelong learning skills that include being able to learn independently and continuously, adapting to new and developing technologies. and thinking questioningly about tedınological changes

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


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