We use cookies to improve your experience on this website. Read More Allow Cookies

Key Info

  • Course CodeCR_EBMDM_7
  • Field of StudyBiomedical Engineering,Mechanical and Manufacturing Engineering
  • Type of CourseCertificate
  • Type of QualificationSpecial Award
  • Type of Study Part time
  • Application Closing Date 13th January 2020
  • Level7
  • LocationCIT Bishopstown Campus
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. Duration: one evening per week for 13 weeks.

All part-time programmes at CIT will run subject to sufficient student numbers. Where a programme cannot proceed, applicants will be contacted and advised on alternative study options.

An Information session will take place on Wednesday 4th September 2019 from 5.30pm to 7.00pm at the CIT Bishopstown Campus. Institute staff will be in attendance to offer career guidance and assistance.

Students should note that Fees quoted relate to the academic year 2019-2020 only and are subject to change on an annual basis. Except where stated, course fees cover the cost of tuition only.

Course fees must be paid before attending lectures.

For more information on Fees, please visit fees/students

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


Course Fee

€1,450*(includes course notes and exam fee)
* Discounts available for groups of three or more.
 

Duration: One evening per week for 13 weeks. (Mondays 6pm - 9pm)


Overview

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.


Content
  • 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.

Award

Certificate in Introduction to Biomedical Devices, Special Purpose Award 10 ECTS credits at Level 7 on the National Framework of Qualifications, awarded by Cork Institute of Technology.

This course is open to anyone with a minimum of two years industrial experience.

Personal Assistant