DISS09003 2013 Medical Technology Regulatory Affairs DISSERTATION

General Details

Full Title
Medical Technology Regulatory Affairs DISSERTATION
Transcript Title
DISSERTATION
Code
DISS09003
Attendance
N/A %
Subject Area
DISS - Dissertation
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
30 - 30 Credits
Duration
Semester
Fee
Start Term
2013 - Full Academic Year 2013-14
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_M09 201500 Master of Science in Medical Device Regulatory Affairs SG_SMEDI_M09 201600 Master of Science in Medical Device Regulatory Affairs SG_SMEDI_M09 201900 Master of Science in Medical Technology Regulatory Affairs
Description

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. This module aims to equip participants with the requisite advanced knowledge, understanding and skills to perform medical device related research using traditional and emerging research designs informed by a critical awareness of developments at the forefront of legislation and practice in the medical device industry.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Articulate and elaborate an understanding of current thinking on the nature of medical device industry challenges and the value of related research in that context.

2.

Articulate and elaborate an awareness of the ethical dimensions and philosophical consideration relating to the device industry in a range of contexts.

3.

Manage a research project combining independent study, support sessions and supervision effectively.

4.

Write a coherent research proposal with an acceptable research question or hypothesis.

5.

Conduct a critically focused literature review.

6.

Analyse data according to accepted models of analysis, showing awareness of alternative models of analysis and theoretical frameworks.

7.

Sustain from the evidence obtained, a reasoned argument and draw consistent and coherent conclusions from the research evidence.

8.

Express the relevance and significance of the outcomes/ conclusions of the research project.

9.

Reflect self-critically on the outcomes/conclusions of the enquiry and on the research process itself.

10.

Write a dissertation which meets postgraduate standards of technical expertise investigating the subject area or testing the hypothesis outlined in the research proposal.

11.

Develop the skills to present and defend aspects of their research at seminars, conferences and vivas.

Teaching and Learning Strategies

Outline of Stages in Process:

Agreement of project title/plan between supervisor and student.

Submission of project plan with Gant chart to supervisor.

Manage project (report, analysis and conclusions) combining independent study with support from supervisor.

Submission of dissertation (circa 25,000 words).

The bound dissertation is dual graded by the internal supervisor and another examiner.

Viva examination by internal /or external examiners.

 

Module Assessment Strategies

Assessment Strategies:

A dissertation of circa 25 thousand words must be sucessfully completed for award of the M.Sc. Ongoing assessment throughout compilation of dissertation will be via assessment of project plan, project log, presentations, final report and viva.

 

The following statements describe generally the threshold level of competence for successful completion of the M.Sc dissertation and assessment shall be based on these criteria:

·      Knowledge base extends to a systematic understanding and critical awareness of topics which are informed by the forefront of the discipline.

·      Problems of an unfamiliar nature are tackled with appropriate methodology and taking into account the possible absence of complete data.

·      Experimental work is carried out independently and with some originality.

·      Substantial research project at the forefront of the discipline is completed effectively.

·      Generic skills are developed appropriately for professional practice.

 

Repeat Assessments

Per Marks and Standards.

Module Dependencies

Prerequisites
REGU09003 201500 Technical Report Writing

Indicative Syllabus

A dissertation of circa 25 thousand words must be sucessfully completed for award of the M.Sc.

Outline of Stages in Process:

Agreement of project title/plan between supervisor and student.

Submission of project plan with Gant chart to supervisor.

Manage project (report, analysis and conclusions) combining independent study with support from supervisor.

Submission of dissertation (circa 25,000 words).

The bound dissertation is dual graded by the internal supervisor and another examiner.

Viva examination by internal /or external examiners.

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment A dissertation of circa 25 thousand words must be sucessfully completed for award of the M.Sc. Ongoing assessment throughout compilation of dissertation will be via assessment of project plan, project log, presentations, final report and viva. The marks will be allocated as follows; Supervisor continuous assessment (15%), final report (65%) and presentation plus viva (20%). Coursework Assessment UNKNOWN 100 % OnGoing 1,2,3,4,5,6,7,8,9,10,11
             
             

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Independent Learning UNKNOWN Self study 600 UNKNOWN 600.00
Directed Learning Not Specified Independent Learning 1 Weekly 1.00
Total Part Time Average Weekly Learner Contact Time 1.00 Hours

Module Resources

Non ISBN Literary Resources

Supervisor may recommend relevant books/resources.

Other Resources

None

Additional Information

None