Medical Device Design Fundamentals

Module code: MEP56BM9 / MEU44B15 · Semester: Semester 1

Resources

• Module descriptor (TCD)

Questions by Year

0 of 7 done · tick papers and add notes as you go

• 2025/26: Paper 11 -25 · Paper 11 -25
• 2024/25: Paper 1 · Paper 1
• 2023/24
• 2022/23
• 2019/20

Papers open on tcd.ie (sign in to TCD first).

Topics

• Clinical trial data and relevant anatomy LO2
• Intellectual property strategy LO3
• Regulation and risk analysis LO1
• Manufacturing requirements and reimbursement LO1, LO4
• Case studies of successful and failed devices LO2

Learning outcomes

1. Understand medical device regulation in the US and EU
2. Use engineering principles to explain why devices succeeded or failed
3. Understand patents in medical device design
4. Understand legal and ethical aspects of device development

Summarised from the module descriptor, checked November 2026.