MEC8056 : Medical Devices Regulatory Requirements
- Offered for Year: 2024/25
- Module Leader(s): Professor Tom Joyce
- Lecturer: Dr Sylvia de Mars, Dr Ilke Turkmendag
- Owning School: Engineering
- Teaching Location: Newcastle City Campus
Semesters
Your programme is made up of credits, the total differs on programme to programme.
| Semester 2 Credit Value: | 20 |
| ECTS Credits: | 10.0 |
| European Credit Transfer System | |
Aims
• Introduce the importance of regulatory requirements to medical devices.
• Provide knowledge and understanding of key medical devices, as case studies, which have come to market and yet have led to significant patient concerns and societal impact.
• Raise critical awareness of regulatory aspects relevant to medical devices.
Outline Of Syllabus
Definitions of a medical device
Case studies of recent medical devices where the regulatory process may have failed.
Different national and international medical device regulatory systems.
Teaching Methods
Teaching Activities
| Category | Activity | Number | Length | Student Hours | Comment |
|---|---|---|---|---|---|
| Scheduled Learning And Teaching Activities | Lecture | 6 | 1:00 | 6:00 | Lectures on remaining course material, aside from case studies |
| Scheduled Learning And Teaching Activities | Lecture | 3 | 2:00 | 6:00 | Two-hour lectures to introduce case studies. |
| Guided Independent Study | Assessment preparation and completion | 1 | 50:00 | 50:00 | Preparation and completion of work around the individual assignment and computer examination. |
| Structured Guided Learning | Academic skills activities | 9 | 3:00 | 27:00 | Guided critical reading activities around each lecture. |
| Scheduled Learning And Teaching Activities | Drop-in/surgery | 4 | 1:00 | 4:00 | Open office to allow students to come and ask any questions |
| Guided Independent Study | Independent study | 1 | 106:00 | 106:00 | Independent Study |
| Scheduled Learning And Teaching Activities | Module talk | 1 | 1:00 | 1:00 | Induction lecture to introduce the module |
| Total | 200:00 |
Teaching Rationale And Relationship
Lectures will introduce the teaching material, which will cover contemporary medical device regulation in various countries to indicate the global need for and reach of medical device regulation. Beginning with identifying what defines a medical device, the lecture material will go on to describe different classes of implants and the various risk levels that frame these classes. Teaching material will then introduce three recent, large-scale ‘scandals’ involving medical devices and, through these taught case studies, analyse in detail issues and potential improvements to medical device regulation. One of these case studies will be assessed in an individual assignment, which will also require context to be explained and thus evaluate student's understanding of taught course material. Private study supports the students' self-study in reading around the lecture material and the associated scientific literature.
Assessment Methods
The format of resits will be determined by the Board of Examiners
Exams
| Description | Length | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|---|
| Digital Examination | 45 | 2 | A | 50 | Digital assessment covering whole syllabus. |
Other Assessment
| Description | Semester | When Set | Percentage | Comment |
|---|---|---|---|---|
| Written exercise | 2 | M | 50 | 1000 words maximum |
Formative Assessments
Formative Assessment is an assessment which develops your skills in being assessed, allows for you to receive feedback, and prepares you for being assessed. However, it does not count to your final mark.
| Description | Semester | When Set | Comment |
|---|---|---|---|
| Computer assessment | 2 | M | Regular online quizzes are offered to help reinforce lecture material and guide student learning. |
Assessment Rationale And Relationship
The assessment will consist of two parts. First, a computer based, multiple choice question exam covering the material delivered across the whole syllabus. Second, an individual assignment which tests the student’s ability to appraise the scientific literature on a contemporary ’scandal’ regarding medical device regulation and thus the areas in which improvements have been, or could be, made. The assignment will also require context to be described and thus knowledge of the taught material will be assessed. Regular computer-based formative assessments will allow students to test their learning of the taught material.
Reading Lists
Timetable
- Timetable Website: www.ncl.ac.uk/timetable/
- MEC8056's Timetable