Registry

Module Specifications

Archived Version 2010 - 2011

Module Title	Product Development and Regulatory Compliance
Module Code	MM371
School	School of Mechanical and Manufacturing Engineering
Online Module Resources
Module Co-ordinator	Dr Garrett McGuinness	Office Number	S377
Level	3	Credit Rating	5
Pre-requisite	None
Co-requisite	None

Module Aims

7 To further the student's understanding of product design and development by building on Module MM222 and explore in detail the key elements and constraints to be considered in medical device design.7 To familarise the students with the primary regulatory issues affecting medical device design and production.7 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

Having successfully completed this module the students will: 7 Be able to prepare Technical files and Design dossiers in accordance with regulatory requirements.7 Have a good understanding of the regulatory and statutory obligations which must be complied with by medical device industries.7 Be capable of performing device design and performance evaluation in line with good engineering practice and regulatory requirements.7 Be capable of adequately documenting procedures and product development related details in compliance with design control requirements and good engineering practice.

Indicative Time Allowances
	Hours
Lectures	24
Tutorials	24
Laboratories	0
Seminars	0
Independent Learning Time	27

Total	75
Placements
Assignments

NOTE

Assume that a 5 credit module load represents approximately 75 hours' work, which includes all teaching, in-course assignments, laboratory work or other specialised training and an estimated private learning time associated with the module.

Indicative Syllabus

¿ The place of Quality Assurance & Regulatory compliance in the Medical Device industry.¿ Medical Device Directive 93/42/EEC (MDD)¿ Active Medical Device Directive (AMDD)¿ CE Marking of Conformity and Technical File content and preparation.¿ Design Controls and Design Dossiers creation¿ FDA Quality System requirements (QSRs) and GMPs¿ FDA Code of Federal Regulations¿ ISO 9000 Quality Assurance System¿ EN 4600 Quality systems for Medical Devices.¿ Medical Device related Standards (International and National)¿ Product Reliability: basic concepts, product liability, graphical methods, system analysis¿ Reliability Prediction: Failure Mode Evaluation Analysis (FMEA), Fault Tree Analysis (FTA), EN 1441 - Medical Device Risk Analysis.¿ Post Market Surveillance and Product development: feed-back mechanism, Vigilance reporting, corrective and preventive actions, collating data, trend analysis and statistics.¿ Design of experiment: One factor at a time ext., weighting exp., fractional factorial design.¿ Pre-clinical testing and product evaluation: experimental analysis, numerical analysis, mechanical testing, clinical trials.¿ Sterilisation : method, validation.¿ Case Studies: (analytical & numerical design analysis)

Assessment
Continuous Assessment	100%	Examination Weight	0%

Indicative Reading List

EN ISO 9001Quality systems - Model for quality assurance in design/development, production, installation and servicing. Council Directive 93/42/ECC , Official Journal of the EC, No.L 169/1, 1993.Trautman, K.A., The FDA quality system requirements guidebook for Medical devices, (ISBN 0-87389-377-8)FDA Code of Federal Regulations, chapter 21, Parts 800-1299.Bergman, B. & Klefsjo, B. Quality - from customer needs to customer satisfaction, McGraw-Hill, 1994.

Programme or List of Programmes

BMED

B.Eng. in Biomedical Engineering

BSSA

Study Abroad (DCU Business School)

BSSAO

Study Abroad (DCU Business School)

ECSA

Study Abroad (Engineering & Computing)

ECSAO

Study Abroad (Engineering & Computing)

HMSA