Biomedical Device Manufacture - Cork
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.
| Award Name | Special Purpose Certificate (Level 7 NFQ) |
|---|---|
| NFQ Classification | Special Purpose |
| Awarding Body | Munster Technological University |
| NFQ Level | Level 7 NFQ |
| Award Name | NFQ Classification | Awarding Body | NFQ Level |
|---|---|---|---|
| Special Purpose Certificate (Level 7 NFQ) | Special Purpose | Munster Technological University | Level 7 NFQ |
Duration
One evening per week (Tuesdays) for 13 weeks (3 hours, delivered fully online).
Entry Requirements
Admission Requirements
This course is open to anyone with a minimum of two years industrial experience.
Note: Places are limited for this course. Eligible candidates will be considered on a first come first served basis.
Further information
The next course commences on 22nd January 2024.
MTU Bishopstown Campus, Cork.
Places Limited
€1,450* (includes course notes and exam fees).
*Discounts available for groups of three or more.
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.
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.
The programme also 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 Practise (GMP) system and the operation of regulatory bodies such as FDA/IMB.
• Anatomy
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; cathether 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.
• Packaging
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.
• GMP
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
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.
Awarding Body
MTU: Certificate in Biomedical Device Manufacture, Special Purpose Award 10 ECTS credits at Level 7 on the National Framework of Qualifications.
T: 021 432 6264
E: CammsCork@mtu.ie
W: www.camms.ie