Registry

Module Specifications

Current Academic Year 2012 - 2013
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
Online Module Resources
Module Teacher	Garrett McGuinness
NFQ level	8	Credit Rating	5
Pre-requisite	None
Co-requisite	None
Compatibles	None
Incompatibles	None

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 aproduct with regulatory and statutory requirements. Defend the proposedconformance plan.

Workload	Full-time hours per semester
*Type*	*Hours*	*Description*
Lecture	24	Lectures
Tutorial	12	Tutorials and project advice sessions
Group work	48	Group project on Technical File Preparation
Independent learning	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	100%	Examination Weight	0%

Course Work Breakdown
Type	Description	% of total	Assessment Date
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
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