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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: 03 December 2024

MTE-40049 - Medical Devices Design: Regulatory Frameworks
Coordinator: Peter Ogrodnik Tel: +44 1782 674996
Lecture Time: See Timetable...
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

This module aims to develop the awareness of the regulatory frameworks that control this exciting environment in order to be able to design components and products successfully within the context of medical devices and healthcare technologies. Particular emphasis will be placed on design within a highly regulated environment. Working in teams is an essential aspect of design, you will be given the opportunity to work in teams and reflect on team performance throughout the module.

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

1: Portfolio weighted 25%
Personal Reflection


2: Coursework weighted 75%
Essay based in group work


The University undertakes a continuous review of its teaching and research provision to ensure programmes are of a high quality and changes may be made to modules where it is necessary and reasonable to do so. Please be aware that minor changes to modules, such as a change to an individual assessment, can occur up until enrolment, although we endeavour to give you as much notice as possible of any changes. 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/legalgovernancecompliance/governance/actcharterstatutesordinancesandregulations/studenttermsconditions/

Last Updated: 03 December 2024