Postgraduate Course: Medical Devices (MCLM11013)
Course Outline
| School | School of Molecular, Genetic and Population Health Sciences |
College | College of Medicine and Veterinary Medicine |
| Course type | Online Distance Learning |
Availability | Not available to visiting students |
| Credit level (Normal year taken) | SCQF Level 11 (Postgraduate) |
Credits | 10 |
| Home subject area | Molecular and Clinical Medicine |
Other subject area | None |
| Course website |
None |
Taught in Gaelic? | No |
| Course description | Medical devices cover a very wide range of technologies that interact with humans ¿ from simple bandages and dressings to complex imaging equipment such as PET CT scanners. The development of medical devices, in common with pharmaceuticals is highly regulated to ensure safety and efficacy of the products. This module is designed to familiarise candidates with the range of medical devices, the pathway for their approval and to highlight the differences between the device and drug worlds. |
Entry Requirements (not applicable to Visiting Students)
| Pre-requisites |
|
Co-requisites | |
| Prohibited Combinations | |
Other requirements | None |
| Additional Costs | None |
Course Delivery Information
|
| Delivery period: 2013/14 Semester 1, Not available to visiting students (SS1)
|
Learn enabled: Yes |
Quota: None |
Web Timetable |
Web Timetable |
| Course Start Date |
16/09/2013 |
| Breakdown of Learning and Teaching activities (Further Info) |
Total Hours:
100
(
Seminar/Tutorial Hours 5,
Online Activities 100,
Feedback/Feedforward Hours 40,
Formative Assessment Hours 12,
Summative Assessment Hours 10,
Revision Session Hours 8,
Programme Level Learning and Teaching Hours 2,
Directed Learning and Independent Learning Hours
0 )
|
| Additional Notes |
|
| Breakdown of Assessment Methods (Further Info) |
Written Exam
0 %,
Coursework
100 %,
Practical Exam
0 %
|
| No Exam Information |
Learning Outcomes
On completion of this course, the student will be able to:
1. Assign the relevant range of technologies to the term ¿Medical Device¿
2. Explore the implications of UK and European legislation for the control of medical devices
3. Recognise International Standards for Medical Device testing
4. Outline the process of obtaining a CE marking for a product and the commercialisation of a product |
Assessment Information
Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20% |
Special Arrangements
| None |
Additional Information
| Academic description |
Not entered |
| Syllabus |
Not entered |
| Transferable skills |
Not entered |
| Reading list |
Not entered |
| Study Abroad |
Not entered |
| Study Pattern |
Not entered |
| Keywords | Medical devices, first-in-human, safety, efficacy, tolerability, study design, preclinical |
Contacts
| Course organiser | Miss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk |
Course secretary | Mrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk |
|
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