Product Design Control (Medical Device) - MSc

Program Overview

Product Design Control (Medical Device) – MSc

Course Overview

The MSc in Product Design Control (Medical Device) is a specialised, industry-aligned postgraduate programme that prepares professionals to lead and contribute effectively to regulated product development environments. Product Design Controls are a structured framework which transforms innovation and technology into safe, effective, and compliant products. They ensure that regulated industries design the right product and consistently make it correctly every time. The programme strongly focuses on EU MDR, FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366-1. This programme develops core competencies across the entire product lifecycle from early concept to design transfer and post-market surveillance.

Learners will build proficiency in regulatory and quality requirements, risk management, usability engineering, and structured project management. Through intensive coursework, collaborative case studies, and an applied research dissertation, graduates will emerge capable of designing, verifying, validating, and transferring safe and effective products that meet user needs, intended use, and regulatory expectations. The programme is designed for engineers, scientists, regulatory professionals, and quality leaders aiming to transition into or advance within medical device and other regulated industries (including food, pharmaceuticals, aerospace, automotive, and high-tech manufacturing).

Course Details

• Location: Moylish, Limerick City
• Duration: 1 year
• Level: 9
• Course Type: Postgraduate
• Study Mode: Full Time
• Department: Mechanical & Automobile Engineering

Entry Requirements

• A minimum honours bachelor degree (Level 8) in any discipline.
• A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work-based experience and/or ability, evidenced by an RPL portfolio of prior experience and learning
• Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.5

Course Modules

Semester 1

• Product Design Control (10 credits) The learner will understand the importance of achieving the user needs and the linkage between each stage of the Design Control process from Design Input, Design History File, Design and Development Planning, Product Risk Management, Human Factors and Usability Engineering, Design Review, Design Output, Design Validation/Verification, Design Change and Design Transfer.
• **Quality Management (10 credits) Draws from International Standards for Quality Management, teachings of the various quality Gurus, National and International Quality Awards, and self-assessment models. Learners will develop skills to become leaders and innovators in the application of Quality principles techniques and develop as quality management professionals in the service and manufacturing industry.
• Project Management (10 credits) Will introduce formal project management methodologies and the project management environment. Learners’ skills and knowledge will be developed in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module also adopts theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project.
• Dissertation (Year-Long Module) (30 credits) Focuses on preparing a research proposal and applying the findings from the literature review to the design, testing and execution of an in-depth research study. Focusing on Interpretation, reporting of findings, and formulating justified conclusions that address the research’s original aims and objectives.

Semester 2

• Process Design Standards and Regulatory Affairs (10 credits) Provide learners with a fundamental understanding of EU and international regulatory systems required during process design. The module will cover the role of regulatory affairs, classification, regulatory structure, and the impact of various regulated industry submission pathways such as medical devices, pharmaceuticals, biopharmaceuticals, and Food manufacturers.
• Design Verification and Validation (10 credits) Evaluates design verification and validation approaches, models, development, implementation, testing and maintenance of a product. The importance and application of design verification and validation management, reporting and risk management in the product lifecycle will be defined and evaluated.
• Product Risk Management (10 credits) Gives the learner the ability to estimate and evaluate associated risks, control the risk, verify the control’s effectiveness, and understand each element of risk management. Work within risk management teams in planning, managing, and developing design failure mode analysis, ensuring that safe and effective products are delivered to the customer.
• Dissertation (Year-Long Module) (30 credits) Focuses on preparing a research proposal and applying the findings from the literature review to the design, testing and execution of an in-depth research study. Focusing on Interpretation, reporting of findings, and formulating justified conclusions that address the research’s original aims and objectives.

Career Opportunities

This programme will enhance a learner’s career in manufacturing, R&D and regulated companies by developing increasing levels of competence, professionalism, critical thinking, problem-solving and decision-making necessary to work in the regulated industry. This equips graduates to work in regulatory affairs, quality or/and engineering and science environments. There are multiple roles a graduate from the programme can seek in areas such as: Product Design Control, Design Control, Product Risk Management, R&D Engineer, Design Assurance Engineer, Product Manager, Regulatory Engineer, Validation Engineer, Quality Engineers, Quality Control, Quality Management, Regulatory affairs Management, Project Engineer, Product Management and Process Engineer.

Further Study

Upon successful completion of this programme, graduates have the opportunity to complete Level 9/10 programmes here at TUS or elsewhere.

Program Outline

Degree Overview:

The MSc in Product Design Control is a one-year, full-time postgraduate program designed to equip learners with the skills and knowledge necessary to excel in product development within regulated environments. The program focuses on the ever-changing landscape of Product Design Control in industries such as Medical Devices, Pharmaceuticals, Automation, Automotive, Food, and Drink. The program aims to provide learners with the competence to understand the primary concepts of product design control and the necessary skills to succeed in product development in a regulated environment. It emphasizes the importance of intended use, user needs, design input, design verification, design validation, and design transfer. Learners will gain the knowledge and skills to manage and contribute to each design stage, including:

• Development planning
• Identifying design inputs
• Developing design outputs
• Verifying that design outputs meet design inputs
• Validating the design output meets user needs
• Reviewing and approving design changes
• Participating in design reviews
• Writing and approving design verification/validation plans, protocols, and reports
• Transferring the design to production
• Maintaining the product while meeting quality and regulatory standards
The program also emphasizes the importance and role of Risk Management throughout the design development process.

Outline:

The program is structured over two semesters, with a total of 14 hours of instruction per week.

Semester 1:

• Product Design Control (10 Credits): This module covers the importance of achieving user needs and the linkage between each stage of the Design Control process, including Design Input, Design History File, Design and Development Planning, Product Risk Management, Human Factors and Usability Engineering, Design Review, Design Output, Design Validation/Verification, Design Change, and Design Transfer.
• Quality Management (10 Credits): This module draws from International Standards for Quality Management, teachings of various quality gurus, National and International Quality Awards, and self-assessment models.
Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques, developing as quality management professionals in the service and manufacturing industry.
• Project Management (10 Credits): This module introduces formal project management methodologies and the project management environment.
Learners will develop skills and knowledge in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module also adopts theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project.
• Dissertation (Year-Long Module, 30 Credits): This module focuses on preparing a research proposal and applying the findings from the literature review to the design, testing, and execution of an in-depth research study.
It emphasizes interpretation, reporting of findings, and formulating justified conclusions that address the research's original aims and objectives.

Semester 2:

• Process Design Standards and Regulatory Affairs (10 Credits): This module provides learners with a fundamental understanding of EU and international regulatory systems required during process design.
It covers the role of regulatory affairs, classification, regulatory structure, and the impact of various regulated industry submission pathways, such as medical devices, pharmaceuticals, biopharmaceuticals, and Food manufacturers.
• Design Verification and Validation (10 Credits): This module evaluates design verification and validation approaches, models, development, implementation, testing, and maintenance of a product.
It defines and evaluates the importance and application of design verification and validation management, reporting, and risk management in the product lifecycle.
• Product Risk Management (10 Credits): This module equips learners with the ability to estimate and evaluate associated risks, control the risk, verify the control's effectiveness, and understand each element of risk management.
Learners will work within risk management teams in planning, managing, and developing design failure mode analysis, ensuring that safe and effective products are delivered to the customer.
• Dissertation (Year-Long Module, 30 Credits): This module focuses on preparing a research proposal and applying the findings from the literature review to the design, testing, and execution of an in-depth research study.

Careers:

The program is designed to enhance a learner's career in manufacturing, R&D, and regulated companies by developing increasing levels of competence, professionalism, critical thinking, problem-solving, and decision-making skills necessary to work in the regulated industry. Graduates are equipped to work in regulatory affairs, quality, engineering, and science environments. Potential roles include:

• Product Design Control
• Design Control
• Product Risk Management
• R&D Engineer
• Design Assurance Engineer
• Product Manager
• Regulatory Engineer
• Validation Engineer
• Quality Engineers
• Quality Control
• Quality Management
• Regulatory Affairs Management
• Project Engineer
• Product Management
• Process Engineer

Other:

The program is designed in conjunction with industry, and various companies may provide work placement for students on the program (subject to availability). The work placement is optional and not a mandatory requirement for students to take up. The program runs over 2.5 days, with students attending classes two to three days a week. The remaining four hours of instruction are delivered online on Monday.