Medical Device Regulatory Affairs and Quality

Higher Diploma in Science

Course Details

Course Code	SG_SMEDI_L08
Level	8
Duration	2 years
Credits	60
Method of Delivery	Online
Campus Locations	Sligo
Mode of Delivery	Part Time

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Course Overview

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 ATU 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 and quality. Upon successful completion of the programme, participants receive an NFQ Level 8 award of 60 credits.

The programme objectives are:

To produce graduates with the essential breadth and kind of knowledge, skills set and competencies required to function in specialist roles in the medical technology regulatory affairs function, to upskill medical technology professionals in the regulatory framework in their existing roles and to be capable of contribution to regulatory projects and projects with a regulatory element in a medical device company environment.
To ensure that participants have sufficient skills and knowledge to employ a fundamental level of data analysing, sythesising, summarising and writing skills in a regulatory environment.
To ensure that participants can communicate and defend scientific data and findings in a variety of forms to regulatory agencies, medical care systems, internal personnel and the public.
To ensure participants have the skills and ability to function within, and adapt to, a changing technical work environment and evolving regulatory frameworks.
To ensure the participants can provide appropriate input and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.

Course outline:

The programme consists of a two year part-time Level 8 Higher Diploma in Medical Technology Regulatory Affairs and Quality (60 credits). The programme shall be 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 will be provided by ATU Sligo, and University of Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners.

The programme consists of 12 modules, each worth 5 ECTS. The programme is delivered over four semesters (two academic years). Three modules are delivered per semester.

Assessment of students will be through continuous assessment of each module, which will include written assignments, workshop-based problem solving, and open-book exams using multiple choices, matching questions as well as short and long answer questions.

Who teaches this course?

The programme will be delivered by academic staff from University of Galway and ATU Sligo, with expertise in Regulatory Affairs & Quality, with guest lectures and workshops involving Regulatory Affairs/Quality experts from the Medical technology industry sector.

Course Details

Year 1

Semester	Module Details	Credits	Mandatory / Elective
1	Introduction to Quality Management Systems This module aims to provide students with an introduction to Quality Management and an understanding of setting up a basic QMS and its implementation. It also aims to provide the students with an understanding of the requirement for a quality management system and how to design this quality system under the 21 CFR 820 or ISO13485 headings. Learning Outcomes 1. Describe the evolution of Quality Management SystemsincludingtheFutureofQuality;Quality4.0 2. Describe a basic QMS and its componentsaswellasQualityManagementsystemsinadigitalage 3. Explain the application and requirements of a QMS as prescribed by 21CFR 820(andintegrationofISO13485:2016asconsensusstandard)andwithENISO13485:2016 4. ExplaintheapplicationandrequirementsofongoingandfutureregulatorybodylegislativeprogramsalignedwithmeetingindustryneedsforQuality4.0 5. Describe the integration of operational excellence methods; Lean and Six Sigma with quality to implement and achieve continuous quality improvement in the MedTech industry 6. Illustrate the audit requirements of a QMS and how to deal with auditors. 7. Understand how to apply ethics and scientific integrity to professional practice. 8. Describeskillsetforthefuturequalityengineersinthesmartfactory;thebarriers,enablers,components,andsmartdigitaltechnologiesinvolvedinQuality4.0deployment	05	Mandatory
1	Fundamentals of EU Medical Device Regulations This module aims to provide students with an introduction to and a fundamental understanding of current and upcoming EU legislation as it applies to medical devices and to provide students with an understanding of the EU classification system and potential regulatory pathways for placing medical devices on the market in the EU. It also aims to provide the students with an understanding of the utilisation of standards and guidance documents (MEDDEVs, NBOGs and NBMEDS). Learning Outcomes 1. Describe the evolution of current legislation and reasons for upcoming revised legislation 2. Classify a medical device under EU requirements 3. Analyse key guidance documents 4. Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessment routes 5. Make change control assessments for common change types 6. Identify the key documents required in technical documentation to support an EU regulatory submission 7. Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority 8. Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements	05	Mandatory
1	Auditing and Compliance This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation and the tools required by an effective auditor. In addition, it also introduces corrective and preventive action, non conformance reporting and ongoing compliance. Learning Outcomes 1. Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtech products in a GMP environment. 2. Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing 3. Source, interpret and apply GMP principles to different case scenarios 4. Role play in a multidisciplinary team of auditors within a GMP environment 5. Critique the performance of a systematic and independent examination of the effectiveness of a quality system 6. Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions 7. Evaluate non conformance statements and understand the non conformance management process	05	Mandatory
2	Fundamentals of US Medical Device Regulations This module aims to provide students with an introduction to and a fundamental understanding of current US legislation as it applies to medical devices and to provide students with an understanding of the US FDA classification system and potential regulatory pathways for placing medical devices on the market in the US. It also aims to provide the students with an understanding of the utilisation of standards and FDA guidance documents. Learning Outcomes 1. Describe the evolution of current legislation 2. Classify a medical device under US requirements 3. Analyse key guidance documents and consensus standards and key FDA medical device databases 4. Define an appropriate regulatory pathway for a number of device classifications 5. Make change control assessments for common change types 6. Identify the key documents required in technical documentation to support a US regulatory submission 7. Evaluate how to interact effectively with FDA agents/reviewers 8. Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDE database	05	Mandatory
2	Risk Management and Design Control This module will enable students to understand the role of Risk assessment through the design process and product lifecycle. Learning Outcomes 1. Analyse the concept of Risk Management 2. Describe a basic Risk management system and its components 3. Explain the application and requirements of Design & Risk Management under 21CFR 820 4. Explain the application and requirements of Design & Risk Management under ISO14971 5. Describe the risk management tools used to help manage risk in the product lifecycle	05	Mandatory
2	Validation and Calibration This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation and the tools required for effective implementation This module will prepare students to undertake different validation roles and will equip the student to complete many validation activities within their organisation. The impetus for the development of this module has emerged from industry needs and the course content has been designed to meet this industry need. This module covers the core aspects of interpreting and/or setting quality characteristics and their verification through appropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrological requirements from quality characteristics through instrument selection, evaluation and on-going calibration so that the student is fully aware of the purpose and operation of a good measurement management system. Learning Outcomes 1. Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment. 2. Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration 3. Outline the properties of a good measurement management system and how it links to validation 4. Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture 5. Critique risk analysis and evaluation and how it relates validation 6. Source and interpret the industry standard guidelines in use for validation within a GMP environment. 7. Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.	05	Mandatory

Year 2

Semester	Module Details	Credits	Mandatory / Elective
1	Fundamentals of Global Medical Device Regulations This module aims to provide students with an introduction to and a fundamental understanding of applicable legislation to medical devices in key markets outside EU and US such as Canada, Australia, Japan and emerging markets. The module will provide students with an understanding of the semantics of each classification system and potential regulatory pathways for placing medical devices on the market in global markets. The module will outline and the legal basis for the use of a Notary Public and documents such as Certs of Free Sale, legalised and consularised documentation. Learning Outcomes 1. Recognise and describe the reason for use of The Hague Convention, Notary Public, Legalisation and Consularisation of documentation 2. Demonstrate an understanding of the basics of applicable legislation in each market 3. Apply appropriate Classification rules fora medical device under each market 4. Demonstrate an understanding of each regulatory system such that one can facilitate regulatory submissions in each market 5. Navigate basic change control principles for each market 6. Demonstrate an understanding of the outline of the STED document and the function of the IMDRF	05	Mandatory
1	Sterilisation and Biocompatability The aim of this module is to give students an understanding of the importance of sterilisation of medical devices in order to insure there is no risk of microbial contamination following use. The most commonly used sterilisation methods will be discussed, detailing the theory behind the method, advantages and disadvantages and applications of each. Students will also learn about disease causing pathogens, virulence factors and associated risks to public health. This module also introduces the students to biocompatibility testing of medical devices according to the ISO guidelines, highlighting the aims and requirements for a number of assays. An overview of human anatomy, toxicology and pharmacology will also be given to ensure students are aware of the importance and risks associated with poor biocompatibility of medical devices i.e. patient morbidity, immune system response and associated diseases. Learning Outcomes 1. Explain and predict the risks associated with medical device contamination, routes of contamination, microbial pathogenicity and prevention methods. 2. Summarise sterilisation of medical devices, requirements, application of sterilisation methods to specific materials and sterility testing methods. 3. Evaluate the risks associated with medical device materials from a disease risk and organ biocompatibility view and Demonstrate an understanding of toxicity testing incorporating both target organ and systemic endpoints. 4. Show an ability to interpret biocompatibility testing data generated following testing and to use this to determine a materials level of compatibility. 5. Demonstrate an understanding of the requirements (ISO) to be met and adhered to when ensuring a medical device is both suitably sterilized and biocompatible pre and post sterilisation.	05	Mandatory
1	Operations Management and GMP This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a GMP environment. Learning Outcomes 1. DebateManufacturing & Operations Engineering functions and the importance of Operations Engineering Strategy in Product and Service design, Process Technology and Quality Control. 2. Recognise and Define GMP, Manufacturing types and layouts and describe how to balance a line 3. Explain Purchasing, Logistics, and Supply Chain Management concepts as well as Planning and Inventory control in the context of a GMP organization. 4. Explain Industry 4.0 in the context of MedTech 4.0; definition, technologies, various Operations strategies in the context of a GMP organisation. 5. Summarise and explainOperational Excellence; Lean philosophy, Six Sigma;AgileProject Planning in the context of GMP Operations Management. 6. Illustratedata analytics; tools and techniques and calculations to demonstrate understanding and application of the learning outcomes.	05	Mandatory
2	Fundamentals of Medical Device Clinical Trials This module aims to provide students with an introduction to and a fundamental understanding of how clinical trials are designed to address questions regarding the safety and effectiveness of medical devices. This course addresses the practical issues in the design of medical device trials and protocol development, as well as broader issues related to clinical trial design and interaction between the regulators and sponsors. Learning Outcomes 1. Outline and evaluatethe reason for current regulations regarding the conduct of clinical trials 2. Recognise and describe theFDA IDE regulations and the ISO14155 requirements 3. Debatethe key roles of individuals involved in clinical research and Describe the key elements of clinical trial design and ICH GCP 4. Evaluatethe key types of clinical trials and Describe the key elements of clinical trial design and ICH GCP 5. Relate Ethical principles and human subject protection and Informed Consent requirements 6. Appraisethe impact of MEDDEV 2.7.1. Rev 4 for Clinical Evaluation in EU and some of the most significant changes	05	Mandatory
2	Introduction to Market Vigilance and Labelling This module introduces the students to labelling and post market requirements for medical devices. It aims to develop the students understanding of what a post market surveillance plan is and how to collect, analyse and respond to data on device safety and performance after market approval. It also aims to provide students with knowledge of the labelling requirements for medical devices. Learning Outcomes 1. Interpret and explain global statutory reporting requirements including local interpretation and current expectations 2. Appraise post market surveillance requirements and requirement for development of a post market surveillance plan 3. Evaluate the components of a complaint management including assessment, evaluation and response to post market data. 4. Demonstrate knowledge of the requirements for all types of potential field actions including field safety corrective actions, advisory notices and recalls. 5. Evaluate strategies for post market surveillance of medical devices in the US and EU. 6. Communicate an understanding of the EU/US/Global legislation and regulations associated with medical device labelling and global perspectives on UDI, harmonised symbols, structure of IFU, intended use, contraindications, e labelling.	05	Mandatory
2	Technical Report Writing This module will enable students to acquire the research and study skills necessary for successful completion of the Higher Diploma in MedTech Regulatory Affairs and Quality. The module will help students construct technical reports and will develop skills in clear use of language and grammar to ensure compliance. The module will help students develop skills in literature searching, referencing and critiquing peer reviewed literature including data analysis. The module will help students connect the importance of good report writing skills to the workplace and wider society. Learning Outcomes 1. Demonstrate good writing style in a technical document with correct referencing style 2. Conduct and synthesize an academic literature search relevant to a proposed topic 3. Present the research findings in a critically reflective manner which acknowledges the limitations of the research methods and knowledge produced 4. Critically evaluate a technical document in area such as complianceand clearly demonstrate an awareness of relevance to industry/workplace and societal impact 5. Compare methods for data analysis and the presentation of results and compare different methods when presenting different results	05	Mandatory

Examination and Assessment

This programme is assessed via 100% continuous assessment.

On-Campus Attendance Requirement

One optional workshop each year which is an opportunity to meet lecturers and network with other students

Progression

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 University of Galway and ATU Sligo.

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Entry Requirements

Graduates who have a level 7 qualification in a relevant area of Science, Engineering or Technology are eligible to apply for this programme. Applications from candidates who hold a Level 7 primary degree in a non-technical subject, and who have at least five years medical technology industry experience in quality and /or regulatory affairs will be considered. Candidate interviews may be used to assess candidates suitability for the programme. Students applying on the basis of formal qualifications and supplementary accredited prior learning (APL) for core pre-requisites will be required to submit full details and references to the Programme Board for consideration of educational equivalencies. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Sligo and University of Galway.

Fees

Total Fees EU: €9000

Further information on fees

Careers

This programme will equip graduates with essential knowledge and skills to work in a Regulatory Affairs or Quality environment within the highly successful and growing Irish Medical Technology industry sector.

The Level 8 Higher Diploma and Certificate in Medical Technology Regulatory Affairs and Quality programme has been specifically designed to meet the growing requirements of 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 in conjunction with a taskforce comprised of regulatory experts from industry, industry practitioners and representatives from the regional skills for a west and north west.

The Irish Medical Devices Association (IMDA) states “The medical technology sector in Ireland is recognised as one of the five global emerging hubs. The sector employs over 29,000 people in Ireland and is the second largest employer of medtech professionals in Europe. Ireland is one of the largest exported of medical products in Europe with annual exports of €12.6 billion and companies here directly export to over 100 countries worldwide. As many as 18 of the world’s top 25 medical technology companies have a base in Ireland and 50% of the 450 medtech companies based here are indigenous.”

The sector is, by its nature, highly regulated; all disciplines involved in the design, manufacture and distribution of a medical device are controlled by medical device regulations. Given the unique need for regulatory affairs knowledge and understanding at all stages of a medical device product lifecycle there is a strong need for the medical technology industry to have available to it appropriate courses to satisfy this information and skills need. The Forfás National Skills Bulletin 2016 further supports this need as it identified a skills shortage for regulatory professionals and quality control engineers.