Module: Product Development and Regulatory Compliance

Module Specifications..

Current Academic Year 2023 - 2024

Please note that this information is subject to change.

Module Title	Product Development and Regulatory Compliance
Module Code	MM371
School	School of Mechanical and Manufacturing Engineering
Module Co-ordinator	Semester 1: Garrett McGuinness Semester 2: Garrett McGuinness Autumn: Garrett McGuinness
Module Teachers	Garrett McGuinness Richard O'Connor David B. MacManus
NFQ level	8	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

Coursework Only
The reassessment will involve an individual project, presentation and test.

Description

To further the student's understanding of product design and development and explore in detail the key elements and constraints to be considered in medical device design. To familarise the students with the primary regulatory issues affecting medical device design and production. To engender in the student an awareness and appreciation of the nature and critical importance of regulatory compliance to product development in the medical device industry.

Learning Outcomes

1. Identify and explain the regulatory and statutory obligations which must be complied with by medical device industries operating in the EU and the US.
2. Evaluate device design inputs, and devise design outputs together with appropriate verification and validation procedures
3. Apply risk analysis methodologies (Failure Mode Effect Analysis and Fault Tree Analysis) to medical devices
4. Apply appropriate standards to devise biological evaluation test plans for biomaterials
5. Write well organised Technical file and Design dossier documents, in accordance with regulatory requirements as part of a team
6. Prepare a clear oral presentation summarising and justifying the compliance of a product with regulatory and statutory requirements. Defend the proposed conformance plan.

*Type*	*Hours*	*Description*
Workload	Full-time hours per semester
Lecture	24	Lectures
Tutorial	12	Tutorials and project advice sessions
Group work	48	Group project on Technical File Preparation
Independent Study	41	Study for class test
Total Workload: 125

All module information is indicative and subject to change. For further information,students are advised to refer to the University's Marks and Standards and Programme Specific Regulations at: http://www.dcu.ie/registry/examinations/index.shtml

Indicative Content and Learning Activities

Medical Device Directive 93/42/EEC (MDD)
Device classifications, Essential Requirements, conformance routes. The Technical File.

FDA Code of Federal Regulations
FDA Quality System requirements (QSRs) and GMPs

Case Study: Carotid stent and embolic protection system
Device characteristics and Intended Use, Indications, Contraindications, Clinical History, Pre-clinical Studies, In Vitro Product Testing, Animal Testing, Biocompatibility, Sterilisation, Summary of Clinical Studies

ISO 13485 Quality systems for Medical Devices
Design Controls

ISO 14791:2007
Medical devices -- Application of risk management to medical devices

Risk Analysis
Failure Mode Evaluation Analysis (FMEA); Fault Tree Analysis (FTA); Case Study

ISO 10993 Biological Evaluation of Medical Devices
Evaluation and testing within a risk management process; Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity; Part 4: Selection of tests for interactions with blood; Part 5: Tests for in vitro cytotoxicity; Part 12: Sample preparation and reference materials

Sterilisation
Methods, validation

ISO 9001:2008
Quality management systems -- Requirements

Post Market Surveillance and Product Development
Feed-back mechanism, Vigilance reporting

Tissue Engineering and Cell based Therapies
Regulatory Issues

Assessment Breakdown
Continuous Assessment	60%	Examination Weight	40%

Type	Description	% of total	Assessment Date
Course Work Breakdown
In Class Test	2 hour written test	40%	Week 6
Project	Preparation of sample Technical File	50%	Week 6
Presentation	Presentation and defence of Technical File	10%	Week 6

Reassessment Requirement Type
Resit arrangements are explained by the following categories; 1 = A resit is available for all components of the module 2 = No resit is available for 100% continuous assessment module 3 = No resit is available for the continuous assessment component
This module is category 1

Indicative Reading List

Official Journal of the EC: 1993, Council Directive 93/42/ECC, No.L 169/1,

Other Resources

None

Programme or List of Programmes

BMED	B.Eng. in Biomedical Engineering
BMEDI	B.Eng. in Biomedical Engineering
CAM	B.Eng. Mechanical & Manufacturing Eng
CAMI	B.Eng. in Mechanical & Manufacturing Eng

Date of Last Revision

04-DEC-08

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