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:

    11th January 2022. Please note that this course is delivered fully online.

Course duration:

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

Admission Requirements:

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

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 and Delivery: One evening (Tuesday) per week for one semester (13 weeks). The course is delivered fully online.


Course fee: €1,450


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

Detailed module information is available here

  • 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. 

  • 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.

     

Apply now >>

 

 

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

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