Biomedical Device Manufacture
Field of Study
Biomedical Engineering,Mechanical and Manufacturing Engineering
Type of Course:
Single Module Course
Type of Qualification:
Single Module Course
Type of Study:
Application Closing Date:
11th January 2022. Please note that this course is delivered fully online.
One evening (Tuesday) per week for one Semester (13 weeks).
Applicants are expected to hold a minimum of two years industrial experience.
This programme was developed for anyone seeking employment in or transferring into the Biomedical Devices Sector as well as anyone wishing to enhance their general knowledge of the industry. The programme is structured around common medical disorders which are treated by biomedical devices manufactured in Ireland. On completion, participants will be familiar with a range of disorders, the anatomy and physiology associated with these disorders, the devices used in their treatment, and the processes involved in the manufacture of these devices.
Mechanical, Biomedical & Manufacturing Eng
Duration and Delivery: One evening (Tuesday) per week for one semester (13 weeks). The course is delivered fully online.
Course fee: €1,450
The programme familiarises participants with the engineering requirements and standards that apply to cleanrooms employed in the manufacture of medical devices. The programme looks at the specification of appropriate cleaning, packaging and sterilisation operations for medical devices, the assessment of the safety risks associated with manufacturing operations and the requirements for guaranteeing a safe working environment.
The programme also examines the detailed requirements of a Good Manufacturing Practice (GMP) system and the operation of regulatory bodies such as FDA/IMB.
Detailed module information is available here
General anatomy, Neuro Anatomy, Cariovascular anatomy, Orthopaedics.
- Medical Devices
Devices used in the treatment of neurovascular, cardiovascular, orthopaedic disorders and product development history.
- Manufacturing Processes
Introduction to manufacturing processes; injection moulding, extrusion, wiredrawing; catheter coating process, embolic coil manufacturing.
- Cleanroom Technology
Cleanroom classification; particle size and counting; filter design and performance, cleanroom layout, materials & standards, cleanroom commissioning and qualification.
- Cleaning and Sterilisation Technology
Requirements for cleaning, soil types, cleaning systems organic/aqueous/ semiaqueous), cleaning equipment. Ethylene oxide. Gamma sterilisation, electron beam. Saturated steam – gravity displacement, porous load, ballasted cycles. Dry heat sterilisation/depyrogenation. Microbial inactivation/endotoxin inactivation.
Functions of packaging, packaging requirements for sterilisation, physical & chemical properties of packaging, labelling and packaging control, distribution hazards, production of packages, forming materials and methods, lidding, sealing.
Introduction to GMP, GMP documentation – SOPs/regulatory documentation/ submissions, Role and requirements of the FDA/IMB/Notified Bodies, introduction to 21 CFR820/Medical Devices Directive, planning for audits. Classification of devices. FDA/IMB submissions – 510k/PMA applications.
Validation protocols – Installation, operational and performance qualification. Process validation, design qualification, validation of sterilisation system, design verification, design validation. URS/FDS/FAT/SAT master validation plans. Change control.
Detailed module information is available here.
Certificate in Introduction to Biomedical Devices, Special Purpose Award 10 ECTS credits at Level 7 on the National Framework of Qualifications awarded by MTU.
- Online application is open for course commencing 18th January 2022.
- Please note that applicants will be required to pay an acceptance fee of €250 online if a place on a course is offered. This fee is deductible from the overall course fee.
Note: You will not be charged for applying for the programme by clicking the 'apply now' button, you are only asked to pay an acceptance fee if a place is offered to you and you wish to accept it.
- Please attach and upload any documents such as transcripts, CV, other details relevant to the application.
- This course is delivered fully online.