Certificates in Medical Device Technology & Quality Management (Springboard)Open for Applications
Location: Galway - Dublin Road
NFQ Level: 7
Programme Duration: 30 Weeks
Mode of Study: Part time
Entry Requirements: Pass in the Leaving Certificate (or EU equivalent) if under 23.
No fees for eligible applicants. For eligibility go to www.springboardcourses.ie/eligibility
Want to work in the Medical Device Industry?
Certificate in Medical Device Technology (Level 6) & Certificate in Quality Management (Level 7)
Ideal for anyone who wants to work in a Medical Device company. This sector is particularly strong in Galway.
Includes option of a 3-6 month placement in the Medical Device Sector.
Daytime lectures (Tuesday to Thursday) from September 2017 to May 2018.
For more details on this course and eligibility go to www.springboardcourses.ie
Certificates in Medical Device Technology & Quality Management
The purpose of this course is to provide the skills necessary to work as an Operator, Quality Inspector, Quality Technician, Clinical Monitor, Regulatory Officer or Design Assurance Test Technician in a Medical Device sector company.
The course consists of two Certificates:
- Certificate in Medical Device Technology (20 Credits - Level 6)
- Certificate in Quality/ Excellence Ireland Diploma in Quality (20 Credits - Level 7)
Certificate in Medical Device Technology (20 credits, Level 6)
- Use scientific knowledge to interpret technical issues that may arise within an industrial setting and identify how these issues may be resolved.
- Interpret the regulatory, environmental and health and safety guidelines and how they apply to various situations / operations within the Medical Device sector.
- Work as a team to interpret, analyse and solve technical issues / problems as presented by lecturers from various disciplines and invited guest lecturers.
- Review the design and use of a chosen medical device product.
- Deliver scientific presentations which detail the analysis of an industrial problem and potential solutions to the issues involved.
- Apply knowledge of the regulatory environment surrounding the registration to aid in the registration of such devices.
- Detail and critique the important methods for the manufacture of medical devices.
- Detail, use and validate the key quality tests used in the medical device sector.
- Apply Good Manufacturing Practice and the principles of ISO 13485 to the manufacture and testing of medical devices.
- Detail the key physiological systems pertinent to the medical device sector, for example the cardiovascular system, the renal system, the arterial and venous systems.
- Detail and analyse the materials used in the manufacture of medical devices.
Certificate in Quality Management (20 credits, Level 7)
- Understand the role and function of Quality within the laboratory and Industry.
- Outline the role and function of Good Laboratory Practice (GLP), Quality Assurance (QA), Good Manufacturing Practice(GMP) and Quality Control (QC) within the laboratory and industry.
- Identify the agencies which regulate quality standards.
- Identify the responsibilities of the employee and employer with regard to health and safety in the laboratory and industry.
- Construct non-conformance reports and Corrective And Preventive Actions (CAPA) for breaches associated with Quality Systems in Biopharmaceutical Science companies.
- Design Standard Operating Procedures using laboratory standards and regulatory guidelines.
- Have a good knowledge of GMP, GLP, Validation, Regulatory bodies and Health & Safety regulations.
- Analyse and interpret the GMP guidelines and the legislation governing the manufacture of medicinal products in the EU.
- Assess and critically review work practices / facilities / equipment to ascertain compliance with various standards and the risk to safety of employees.
- Describe the concept of validation and its critical importance in the pharmaceutical industry.
- Work in a quality management role and participate in audits.
- Be familiar with regulatory bodies and licensing of pharmaceuticals.
Prepare and implement a safety statement in compliance with E.U. Directives and National legislation.
To apply for this course, you must go to www.springboardcourses.ie
If under 23, applicants must have passed Leaving Certificate or equivalent
Applicants will be interviewed to determine suitability for entrance to the programme, and the interview will form part of the selection process.
The Springboard Programme is operated by the Higher Education Authority on behalf of the Department of Education and Skills and is co-funded by the Irish Government and the European Union under the Euroepan Structural and Investment Funds Programme 2014-2020.