Medical Technology Regulatory Affairs and Quality (Cert)

Course Overview

The Level 8 Certificate in Medical Technologies Regulatory Affairs and Quality provides students with an introduction to the core elements of the product development lifecycle and the associated role of a Medical Technology Regulatory Affairs and/or Quality professional.  The programme ensures that students acquire a good, fundamental understanding of all applicable regulations and skills to address the ever-changing environment of Medical Technologies Regulatory Affairs and Quality.

 This programme has been designed to meet the growing requirements of Irish Medical Technology companies in filling regulatory and quality assurance roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed jointly by NUI Galway and IT Sligo in conjunction with selected external professionals and industry practitioners who have all the required expertise, knowledge, skills and experience to deliver the education and training required to the highest international standards.

 The course will enable Regulatory Affairs and quality personnel in the Medical Technology industry to understand all current device and diagnostic regulations and to develop the skills necessary to address and prepare for the ever-changing global environment of regulatory affairs. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 30 credits.

 The programme aims are to:

• Provide participants with a fundamental grounding in medical device regulatory and quality requirements.
• Provide necessary training to convert personnel with life sciences qualifications to transition into specialist roles in medical technology quality assurance and/or regulatory affairs functions and upskill medical technology professionals in the regulatory framework in their existing roles. 
• Foster participants’ intellectual development and develop skills to work and communicate effectively through various media

Reduced Fees for ulearning Skillnet Member Companies*

• ulearning Member Fee**: €1,350 per semester
  
• ulearning Non-Member Fee***: €2,025 per semester
  
  * To qualify for ulearning Skillnet membership, an employer must be a private sector company and must be paying their employees fees directly or if employee is paying the fees themselves they must be being reimbursed by their employer. Companies who do not qualify under these criteria may still enrol on the course at the Non-Member rate.
  
  ** Subject to confirmation of funding support for semester 2.
  
  *** Companies who do not qualify under the ulearning criteria may still enrol on the course at the Non-Member rate.

 Click for more information on reduced fees

Key Facts

Entry Requirements

Additional Requirements

Course Outline

• The programme is offered as a one year part-time Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits)
• The Certificate programme is also available for students to undertake in a modular format, enabling students to select any individual module or combination of modules in any year, up to a maximum of 3 modules per semester
•  The module programme offering gives students the option to complete all 6 taught modules five  six years to obtain a Level 8 Certificate

The programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements is provided by the Institute of Technology, Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by industry specialists and practitioners.

 Semester 1 Modules (Each module is 5 ECTS)

1. Introduction to Quality Management Systems
2. Fundamentals of EU Medical Device Regulations
3. Auditing and Compliance

 Semester 2 Modules (Each module is 5 ECTS)

4. Fundamentals of US Medical Device Regulations
5. Risk Assessment
6. Validation and Calibration

Further Education

Following completion of the one year Level 8 Certificate in Medical Technology Regulatory Affairs and Quality (30 credits) students are eligible to continue for a second Year to complete a Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The Higher Diploma award ewill be available from September 2018.

Graduates with the Higher Diploma award will be eligible to apply to undertake the MSc. in Medical Technologies Regulatory Affairs, a part-time distance learning Level 9 programme jointly delivered by NUI Galway and IT Sligo.

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Career Opportunities

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Course Fees

Fees: EU

Fees: Tuition

Fees: Student levy

Fees: Non EU

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