Product Design Control (Medical Devices) – (Postgraduate Diploma, L9, 60 ECTS)

Course Overview

The majority of companies today operate in changeable industries adapting to customer needs, promoting innovation, regulatory requirements and staying competitive. Due to these challenges, products today are continually changing e.g. make it lighter, smaller, faster, smarter. This has increased the demand for people working in product development such as engineers (mechanical, reliability, human factors, software), product/project managers, quality, risk management and regulatory compliance leaders. The aim of the Level 9 Postgraduate Diploma in Product Design Control Management is to equip learners with competence to learn the primary concepts of product design control as well as the necessary things needed in order to be successful in product development in a regulated environment. Particular focus on intended use, user needs, design input, design verification, design validation and design transfer. Learners will have the knowledge and skills to be able to manage and contribute to each stage of the design, development planning, identifying design inputs, developing design outputs, verifying that design outputs meet design inputs, validating the design output meets the user needs, review and approving design changes, participating in design reviews, writing and approving design verification/validation plans, protocols and reports and finally transferring the design to production, maintain the product while meeting quality and regulatory standards. While also understanding the importance and role of Risk Management through each stage of the design development process. The programme will develop the learners’ skills to address and prepare for the ever-changing environment of Product Design Control in sectors such as Medical Device, Pharmaceutical, Automation, Automotive, Food and Drink.

Critical thinking, problem-solving, decision-making, professionalism, and management techniques will be key areas covered by the programme.

As assessments will be mainly industry-based, learners are required to engage with industry and industry representatives in various cross disciples through continuous assessment and industry-based projects. This will prepare learners to be industry ready and apply the transferable skills gained through module content, industry engagement, and strengthened by industry-based assessments.

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 have evidence of a proficiency in the English language for example IELTS 6.5.

Course Content

Semester 1

• Quality Management
  • This module will facilitate an in-depth understanding of quality and quality management, from the various definitions of quality, through to the practical application of systems and processes to manage quality. The module will draw from International Standards for Quality Management, the teachings of the various quality Gurus, National and International Quality Awards, and self assessments models. This module will help the student develop a number of Professional Transferable Skills, such as leadership, strategic direction, system approach, PDCA, and customer focus. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.
• Product Design Control
  • Module aims to provide the learner with a broad overview of product Design Control elements in the product lifecycle. Covering each phase from concept through to sustaining. The learner will understand that the Design Control is an iterative process, throughout which the product design is continuously refined and changes are reviewed, documented, and approved. Through this understanding 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. This module will help the student develop a number of Professional Transferable Skills, such as working within teams in planning, managing and execution of design projects with the ability to be customer focused.
• Project Management
  • Module will introduced formal project management methodologies and the project management environment. Learners skills and knowledge will be developed in the tools and techniques that are documented in the Project Management Body of Knowledge (PMBOK). A significant focus of the module will be on the application of these tools within industry. The module also adopts both theoretical and active learning, as the learner will be required to identify and complete an individual industry-based project. They will complete a set of weekly assignments on their chosen project which, when combined, will give them experience across all of the areas of the PMBOK. They will be fully encouraged to apply theory and analytical tools practically within their industry-based project.

Semester 2

• Product Design Verification and Validation
  • The aim of the Design Verification and Validation module is to provide the learner with a broad overview of design verification and validation activities in a product’s lifecycle. To evaluate 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. This module aims to advance the learner’s transferrable skills, in order to prepare them for industry-based employment, including creative problem-solving, and technical writing.
• Product Risk Management
  • Aims to provide learners with a fundamental understanding of product Risk Management as part of the Design Control process. The module will give the learner the ability to estimate and evaluate associated risks, controlling the risk, and verifying the effectiveness of control. The learner will fully understand each element (Risk Management Plan, Risk (Hazard), Risk Management Report, and Design FMEA) of the Risk Management File which allows them to develop and maintain the file throughout the Design Control process. This module will help the student develop a number of Professional Transferable Skills, such as working within Risk Management teams in planning, managing and development of design failure mode analysis ensuring that safe and effective products are delivered to the customer.
• Process Design Standards & Regulatory Affairs
  • Aims to 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 submission pathways as they apply to medical devices, pharmaceuticals, Biopharmaceutical, and Food manufacture. This module will enhance a learner’s career in regulatory affairs by developing increasing levels of competence and professionalism by obtaining a formal qualification in industry.

Delivery

• This programme will be delivered online from September to April
• Number of Weeks: 12 per semester
• Number of Days/Evenings per week: 3
• Delivery Day/Evening: Monday, Tuesday, Thursday
• Number of Hours per day/evening: 3 hours (lectures) / 1 hour (support classes)

Assessment

• Continuous assessment (100% online). No end of semester exams.

Qualification

• Postgraduate Diploma in Science in Product Design Control, Level 9, 60 ECTS

Fees

• €8,500

Application Deadline

• Deadline for application; 15th August 2025.
• Places are allocated on a first come first served basis, prioritizing unemployed and returning applicants.
• Course will be closed once the maximum number of applicants is reached.
• Courses run subject to viable numbers.

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Product Design Control (Postgraduate Diploma, L9, 60 ECTS) - TUS

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Degree Overview:

The Postgraduate Diploma in Product Design Control Management aims to equip learners with the competence to understand the primary concepts of product design control and the necessary skills for success in product development within a regulated environment. The program focuses on 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 stage of the design process, including:

• Design, 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 emphasizes the importance and role of Risk Management throughout the design development process. It develops learners' skills to address and prepare for the ever-changing environment of Product Design Control in sectors such as Medical Device, Pharmaceutical, Automation, Automotive, Food, and Drink.

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Outline:

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Semester 1:

• Quality Management: This module provides an in-depth understanding of quality and quality management, covering various definitions of quality, practical application of systems and processes to manage quality, International Standards for Quality Management, teachings of quality gurus, National and International Quality Awards, and self-assessment models.
Learners develop skills to become leaders and innovators in the application of Quality principles and techniques, preparing them for senior roles in the service and manufacturing industry.
• Product Design Control: This module provides a broad overview of product Design Control elements in the product lifecycle, covering each phase from concept to sustaining.
Learners understand that Design Control is an iterative process where the product design is continuously refined, and changes are reviewed, documented, and approved. The module emphasizes 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.
• Project Management: This module introduces formal project management methodologies and the project management environment.
Learners develop skills and knowledge in the tools and techniques documented in the Project Management Body of Knowledge (PMBOK). The module focuses on the application of these tools within industry and adopts both theoretical and active learning. Learners identify and complete an individual industry-based project, completing weekly assignments that provide experience across all areas of the PMBOK.

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Semester 2:

• Product Design Verification and Validation: This module provides a broad overview of design verification and validation activities in a product's lifecycle.
It 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 are defined and evaluated. This module advances learners' transferable skills, preparing them for industry-based employment, including creative problem-solving and technical writing.
• Product Risk Management: This module provides a fundamental understanding of product Risk Management as part of the Design Control process.
Learners gain the ability to estimate and evaluate associated risks, control the risk, and verify the effectiveness of control. They fully understand each element (Risk Management Plan, Risk (Hazard), Risk Management Report, and Design FMEA) of the Risk Management File, allowing them to develop and maintain the file throughout the Design Control process. This module develops learners' skills to work within Risk Management teams in planning, managing, and developing design failure mode analysis, ensuring safe and effective products are delivered to the customer.
• Process Design Standards & Regulatory Affairs: This module provides 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 submission pathways as they apply to medical devices, pharmaceuticals, Biopharmaceutical, and Food manufacture. This module enhances a learner's career in regulatory affairs by developing increasing levels of competence and professionalism through a formal qualification in the industry.

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Course Schedule:

• Delivery: Online
• Duration: September 2024 to April 2025
• Weeks: 12 per semester
• Days/Evenings per week: 3
• Delivery Day/Evening: Monday, Tuesday, Thursday
• Hours per day/evening: 3 hours (lectures) / 1 hour (support classes)

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Assessment:

• Continuous assessment (100% online): No end-of-semester exams.

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Teaching:

• Delivery Method: Online
• Faculty: Clodagh Moore (Academic Queries)
• Support Classes: Optional attendance on Thursdays and Fridays

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Careers:

• Potential Career Paths:
• Engineers (mechanical, reliability, human factors, software)
• Product/Project Managers
• Quality, Risk Management, and Regulatory Compliance Leaders
• Opportunities: The program prepares learners for industry-ready roles in various sectors, including Medical Device, Pharmaceutical, Automation, Automotive, Food, and Drink.

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Other:

• Time Commitment: Each 5 credits equate to approximately 100 Total Learning Hours, including class time and work outside of college.
• Class Recordings: All classes are recorded and can be watched back.

Technological University of the Shannon (TUS)

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Overview:

Technological University of the Shannon (TUS) is a multi-campus university in Ireland, offering a wide range of undergraduate and postgraduate programs across various disciplines. It is known for its focus on applied learning and innovation, fostering strong industry ties and providing excellent employment opportunities for its graduates.

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Services Offered:

TUS provides a comprehensive range of services to its students, including:

Admissions & Support:

Admissions guidance, international student support, open days, student finance information, induction programs, and student support services.

Campus Life:

Accommodation options, career and employability services, chaplaincy and pastoral care, disability supports, learning support, student counselling, student health services, sports facilities, student union, clubs and societies.

Faculty Areas:

Business, Hospitality & Humanities, Engineering, Built Environment & Informatics, Sciences, Health & Technology, and Limerick School of Art & Design.

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Student Life and Campus Experience:

TUS prioritizes a student-first approach, offering small class sizes and personalized attention. Students can expect a vibrant campus life with a range of clubs, societies, and sports activities. The university also provides comprehensive support services to ensure a positive and enriching student experience.

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Key Reasons to Study There:

Applied Learning & Innovation:

TUS emphasizes practical skills and real-world application, preparing students for successful careers.

Strong Industry Ties:

The university has strong connections with industry partners, providing students with valuable internship and employment opportunities.

Excellent Employment Opportunities:

TUS graduates are highly sought after by employers, with a strong track record of successful career outcomes.

Vibrant Campus Life:

Students can enjoy a diverse and engaging campus experience with a range of clubs, societies, and sports activities.

Comprehensive Support Services:

TUS provides a wide range of support services to ensure students' academic and personal success.

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Academic Programs:

TUS offers a wide range of academic programs, including:

Undergraduate:

Programs in various disciplines, including business, engineering, science, technology, art, and design.

Postgraduate:

Master's and PhD programs in specialized fields.

Apprenticeships:

Programs in various trades and technical fields.

Flexible & Professional Learning:

Programs designed for working professionals.

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Other:

TUS is a QS 5 Star Rated University, recognized for its high-quality education and research. The university is also actively involved in research and development, with a focus on areas of national and global importance.