REGU09011 2019 Design Assurance, Sterilisation and Biocompatability

General Details

Full Title
Design Assurance, Sterilisation and Biocompatability
Transcript Title
Design Assurance, Sterilisatio
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
09 - NFQ Level 9
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Mary Garvey, Mary Butler
Programme Membership
SG_SMEDI_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology Regulatory Affairs

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of the design assurance process, common sterilization techniques for medical devices, associated standards and validation. It aims to provide a basic understanding of common biocompatibility testing methods and interpretation of results.

Learning Outcomes

On completion of this module the learner will/should be able to;


Demonstrate an ability to generate a biocompatibility testing protocol according to standards.


Interpret and apply the ISO10993 standards for the evaluation of the biocompatibility of medical devices.


Evaluate sterilization methods under various headings to include packaging, products effects, costs etc.


Describe current sterilization methods in use detailing rational and system advantages and disadvantages


 Demonstrate an ability to develop verifiable design inputs and understand the links to risk management activities


Interpret and understand test protocols including risk based acceptance criteria, sample sizes and use of appropriate statistical methods

Teaching and Learning Strategies

The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

Module Assessment Strategies

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

Repeat Assessments

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: DesignAssurance, sterilization techniques for medical devices; sterilization standards; packaging and sterilization; factors to consider in sterilization method choice; Biocompatibility standards; Biocompatibility test methods; Report generation; Characterization of materials/devices.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 WRITTEN ASSIGNMENT Continuous Assessment Assignment 30 % Week 13 1,2,3,5
2 ASSESSMENT Continuous Assessment Open Book Exam 15 % Week 3 2
3 MCQ Continuous Assessment Open Book Exam 10 % Week 6 4
4 laq Continuous Assessment Closed Book Exam 20 % Week 8 4
5 DA Continuous Assessment Closed Book Exam 25 % OnGoing 5,6

Part Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2009-09-25 Biodesign: The Process of Innovating Medical Technologies Cambridge University Press
ISBN 0521517427 ISBN-13 9780521517423

Recognize market opportunities, master the design process, and develop business acumen with this 'how-to' guide to medical technology innovation. A three-step, proven approach to the biodesign innovation process - identify, invent, implement - provides a practical formula for innovation. The experiences of hundreds of innovators and companies, in the form of case studies, quotes and practical advice, offer a realistic, action-orientated roadmap for successful biodesign innovation. Real-world examples, end-of-chapter projects, and Getting Started sections guide the reader through each of the key stages of the process and provide a template to create their own new medical devices. Addressing common medical, engineering, and business challenges to develop well-rounded expertise, this book is the complete package for any biodesign entrepreneur. The text is supported by valuable resources, including up-to-date industry changes: found at

Recommended Reading
2012-02-22 Development of FDA-Regulated Medical Products: A Translational Approach, Second Edition Quality Press
ISBN 0873898338 ISBN-13 9780873898331

Translating promising discoveries and innovations into useful, marketable medical products demands a robust process to guide nascent products through a tangle of scientific, clinical, regulatory, economic, social, and legal challenges. There are so many human and environmental elements involved in shepherding medical advances from lab to launch that the field of medical product development has been referred to as an ecosystem. The purpose of this book is to help provide a shared foundation from which cross-functional participants in that ecosystem can negotiate the product development labyrinth and accomplish the goal of providing both groundbreaking and iterative new medical products. The book is intended for anyone in industry, the public sector, or academia regardless of functional specialty, workplace, or seniority who is interested in medical product development. The years since the publication of the previous edition of this book have seen profound changes in the actions and attitudes of patients, insurers, manufacturers, and the Food and Drug Administration regarding the streamlining of medical product development and approval. What those years have not seen is a concomitant increase in innovative treatments with profound benefits to patients. Despite enormous investments in research by both private and public sources and a surge in scientific and technological advances, new medical products barely trickle into the marketplace. For a variety of reasons, applied sciences necessary for medical product development are not keeping pace with the tremendous advances in basic sciences. Not surprisingly, industry and academia are under substantial pressure to transform discoveries and innovations from the laboratory into safe and effective medical products to benefit patients and improve health. This evolution from bench to bedside has become known as translational research and development, and this approach is what this book illuminates.

Module Resources

Non ISBN Literary Resources

Biomaterials Science: An Introduction to Materials in Medicine

Journal Resources

Journal of Biomaterials Science

Other Resources


Additional Information