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DEGREE REGULATIONS & PROGRAMMES OF STUDY 2015/2016

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DRPS : Course Catalogue : Deanery of Molecular, Genetic and Population Health Sciences : Molecular and Clinical Medicine

Postgraduate Course: Medical Devices (MCLM11013)

Course Outline
SchoolDeanery of Molecular, Genetic and Population Health Sciences CollegeCollege of Medicine and Veterinary Medicine
Credit level (Normal year taken)SCQF Level 11 (Postgraduate)
Course typeOnline Distance Learning AvailabilityNot available to visiting students
SCQF Credits10 ECTS Credits5
SummaryMedical 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.
Course description Not entered
Entry Requirements (not applicable to Visiting Students)
Pre-requisites Co-requisites
Prohibited Combinations Other requirements None
Course Delivery Information
Academic year 2015/16, Not available to visiting students (SS1) Quota:  None
Course Start Semester 1
Timetable Timetable
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 )
Assessment (Further Info) Written Exam 0 %, Coursework 100 %, Practical Exam 0 %
Additional Information (Assessment) Online participation: 25%
Individual project: 25%
Reflective portfolio: 30%
Case scenarios: 20%
Feedback Not entered
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
Reading List
None
Additional Information
Graduate Attributes and Skills Not entered
KeywordsMedical devices, first-in-human, safety, efficacy, tolerability, study design, preclinical
Contacts
Course organiserMiss Michelle Evans
Tel: 0131 537 3326
Email: michelle.evans@ed.ac.uk
Course secretaryMrs Danielle Marlow
Tel: 0131 537 3798
Email: Danielle.Wilson@ed.ac.uk
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