Biomedical Device Manufacture

  • Course Code

    CR_EBMDM_7

  • Field of Study

    Biomedical Engineering,Mechanical and Manufacturing Engineering

  • Type of Course:

    Single Module Course

  • Type of Qualification:

    Single Module Course

  • Type of Study:

    Part time,Online

  • Application Closing Date:

    14th December 2020

Course duration:

One evening per week for one Semester (13 weeks).

Admission Requirements:


Applicants are expected to hold a minimum of two years industrial experience.
 

 

July Stimulus Higher Education Authority (HEA) Initiative
Are you eligible? Most of these courses are free... and some of them you only have to pay 10% of the fee!


 

Please view the 'Apply Tab' above for more information on eligibility. 

 

Course Fee

This Level 7 module is funded through an initiative of the HEA. The module is free of charge if you are unemployed, a homemaker returning to work or are in receipt of the COVID-19 unemployment payment at the time the programme 28th January 2021.

 

If you are in employment, were previously self-employed or are a recent graduate, you may be eligible provided you meet the nationality/visa requirement and residence requirement. These categories of learner are eligible for 90% funding and will be required to pay 10% (€145) of the standard tuition fee.The standard tuition fee for this module is €1,450.

 

These are in line with the current requirements for Springboard courses
https://springboardcourses.ie/eligibility
 

Refund Policy

Students should note that the 10% course fee is non-refundable except in cases where courses do not proceed.

 

 

 

Personal data may be shared with the Higher Education Authority, for example to determine eligibility for funding or for statistical purposes. This will at all times be done in compliance with GDPR and the Data Protection Act 2018. Further information can be found at https://hea.ie/about-us/data_protection/

Course summary

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.

Department(s)

Mechanical, Biomedical & Manufacturing Eng

Duration: One evening per week for  one Semester (13 weeks). 


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.

Detailed module information is available here.


Award

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

Should you have any questions, please do not hesitate to email registration@cit.ie
 

Online application is open (link is at the end of this page) for Returners, the Employed, formerly Self Employed and recent Graduates who meet the eligibility criteria at the time of course commencement (end of November).
 
To progress your application to this programme, two non-academic eligibility requirements must be satisfied. These are your Employment status and your Residency/Nationality status.  
 
Eligibility criteria is in line with the current requirements for Springboard courses https://springboardcourses.ie/eligibility
 
If you require documentation from the Department of Social Protection please call the customer service line on 071 9193302 to request this letter.
 
This course will be filled on a first come first served basis so it is important to read and follow the below instructions correctly.


Your application will not be assessed further until the supporting documentation is submitted. Please upload the relevant documentation with your application. Please note that all applicants are required to submit a passport or birth certificate (a driving licence will not be accepted).

 

Should you have any questions, please do not hesitate to email registration@cit.ie for assistance.

1. Employment Status 


a)  Unemployed 
Please email supporting documentation that you are currently in receipt of a Department of Employment Affairs & Social Protection payment outlined below, or that you are signing for Social Insurance Contribution Credits. This supporting documentation should be in the form of a receipt of payment or a letter from the Department of Employment Affairs & Social Protection.
Please call the customer service line on 071 9193302 to request this letter
 

  • Jobseekers Benefit 
  • Jobseekers Allowance 
  • One Parent Family 
  • Disability Allowance 
  • Qualified Adults of Working Age 
  • Carers Allowance 
  • Farm Assist/Fish Assist 
  • Widow's, Widower's or Surviving Civil Partner's Contributory or Non-contributory Pension 
  • Blind Pension 
  • Deserted Wives Allowance 

b)  Employed/Self Employed 
Email a copy of your most recent Employment Detail Summary, payslip, other relevant revenue documentation or a letter from your current employer, to confirm employment. 
 
c)  Returner 
A declaration to attest to your employment status must be sworn before a Commissioner of Oaths.  It must be signed, dated and stamped before submission. When this has been completed, please email the form to registration@cit.ie 
 

2. Residency/Nationality Status

As required by Higher Education Authority

  • All applicants are required to submit a passport or birth certificate.  
    Please note driving licence will not be accepted
     
  • Candidates must provide documentation to provide proof that they have been resident in an EU country for 3 of the past 5 years preceding entry of the programme i.e. since January 2016
     
  • Note: The period of residency for holders of Stamp 4 or Stamp 4 EU FAM is calculated from the date of receipt of the Stamp 4. Any period of residency in the state before this date will not be taken into consideration. 

 
Examples of Documents acceptable for evidence of having lived in an EU country 

  • A sworn Affidavit from a solicitor in Ireland confirming residency in Ireland for specific dates (from and to). Your name and passport number to be noted, dated, and stamped by a solicitor’s office.  
     
  • Original letter from a place of work – dated, stamped, and signed by an official there. Dates from and to clearly indicated. 
     
  • P60 from 3 of the last 5 years.

 

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Ciara Lavelle, Centre for Advanced Manufacturing and Management Systems
ciara.lavelle@cit.ie
021 432 6264

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