Biomedical Device Manufacture

Special Purpose Award

Skeleton graphic for Biomedical Engineering course
Skeleton graphic for Biomedical Engineering course
Type of Programme
Part-time, Online
Duration
1 Semester
Course Code
CR_EBMDM_7
Entry Requirements
See details below
Application Deadline
21st September 2024
Location(s)
Cork, Online
Course NFQ Level
Level 7

CAMMS

T: 021 432 6264

Email: (email)

Overview

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.

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 Practice (GMP) system and the operation of regulatory bodies such as FDA/IMB.

 

Course Delivery

One evening per week (Tuesdays) for 13 weeks (3 hours, delivered fully online). The next course commences on 22nd January 2024.

 

What will I study?

Modules:

  • 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; 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.
  • 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.

Credits:

10 

Modules

What is a Module?

A module is a standalone unit of learning and assessment and is completed within one semester. A full-time student will normally study six modules in each semester; part-time and ACCS (Accumulation of Credits and Certification of Subjects) students will have flexibility as to the number of modules taken.

The button below provides a link to all of the University's approved modules for this programme.

View Modules

Entry Requirements

This course is open to anyone with a minimum of two years industrial experience. Please attach and upload any documents such as transcripts, CV, other details relevant to the application.

Note: Places are limited for this course. Eligible candidates will be considered on a first come first served basis.

 

What is RPL?

Recognition of Prior Learning (RPL) is when formal recognition is given for what you already know prior to starting on a programme or module. With recognition of prior learning the focus is on learning and not on experience as such. You can apply for RPL in any MTU accredited programme or module. Programmes which are accredited by professional bodies or any external awarding bodies may have their own procedures for RPL which you should refer to.

Fees

€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.

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