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MTE-40049 - Module Specification
School of Pharmacy and Bioengineering
Faculty of Medicine & Health Sciences

For academic year: 2024/25 Last Updated: 28 April 2024

MTE-40049 - Medical Devices Design: Regulatory Frameworks
Coordinator:
Lecture Time:
Level: Level 7
Credits: 15
Study Hours: 150
School Office:

Programme/Approved Electives for 2024/25

None

Available as a Free Standing Elective

No

Co-requisites

None

Prerequisites

None

Barred Combinations

None

Description for 2024/25


Aims
The aim of this module is to develop a student's formal engineering design ability in order that they could undertake a design project, as a part of a design team and within the context of the regulatory frameworks governing medical devices / healthcare technology.

Intended Learning Outcomes

Interpret existing regulatory frameworks in order to formulate a medical devices "UKCA marking/ CE marking / FDA clearance to market" design strategy: 2
Evaluate and critically appraise at a level commensurate with an engineering designer and an internal auditor to maximise the benefits of quality management per relevant standards and guidelines: 2
Evaluate and critically appraise performance within a team within the context relevant regulatory frameworks: 1

Study hours

Nominal 1-2 hours per week (18 hours) containing a mix of
lectures, seminars and group work: but this may vary dependent on the planned activity.
Guided independent study: 132 hours

School Rules

None

Description of Module Assessment

Please note that for the 2022/23 Academic Year programmes may be adapted to operate in accordance with a flexible, digital approach. This means that there may be some changes made to how modules are delivered and assessed. The latest information will be provided to you by your School in module handbooks. We endeavour to give you as much notice as possible of any changes and details about the circumstance in which changes are made to programmes can be found in the Student Agreement, available at: https://www.keele.ac.uk/student-terms-and-conditions/

Last Updated: 28 April 2024