As a leading network within the Skillnet Ireland group of 70+ networks, Irish Medtech Skillnet continues to support and develop training programmes that ensure that the Skills needs of the present and future workforce are sustained and advanced.
By working closely with Industry, and the members of our promoting organisation, The Irish Medtech Association at Ibec, the network develops and delivers transformative, industry-led training solutions for companies of all sizes in the medical technology and manufacturing sectors.
As the Irish Medtech sector defines its future role, cements its success and establishes its strong position globally within an evolving health ecosystem, it is critical to develop and retain best in class talent to enable the future success and competitiveness of medtech in Ireland. The goal of our network is to ensure that those technical and non-technical skills needs are developed and sustained.
Irish Medtech Skillnet is the high-value talent advisor and catalyst for skills transformation across all segments of the diverse Medtech sector, meeting organisation needs today & into the future.
Dr. Ann O’Connell Head of Funded Projects Medtech & Engineering, Ibecwww.IrishMedtechSkillnet.ie
The Irish Medtech Skillnet is delighted to join MEDDEV Solutions in bringing you this exciting programme which will help you to understand and equip you with the knowledge, skills, and expertise required to conduct rigorous and compliant clinical evaluations of medical devices. Throughout this training, MEDDEV Solutions review the core principles and practices that underpin effective clinical evaluations, while addressing the latest regulatory requirements, real world examples and best practice in the field.
Appreciate the clinical evaluation requirements for all classes of medical device
Explain how equivalence works
Identify when clinical data is and is not required
Select safety and performance outcome parameters
Link QMS processes such as risk management and PMS with clinical evaluation
Define what state of the art is and how it is used
Apply systematic methods to gather and appraise data
Construct your CER to ensure it passes notified body scrutiny
Apply best practices
Programme fee: €950 (€600 after funding)
10 APRIL 2024
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES.
ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
This course is recommended for anyone involved in implementing or maintaining a clinical evaluation file.
- Quality Engineers
- Quality Managers
- Regulatory Professionals
- Clinical Data Evaluators
- Clinical Sponsors
Established in 2017, Meddev Solutions has become a specialist in medical device and pharmaceutical training and consultancy. With our in-depth knowledge of regulatory and quality requirements we only use best practice methodologies throughout our training.
This CQI & IRCA Certified Blended ISO 13485:2016 Internal Auditor Course is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS.
Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. With reference to the PDCA cycle, explain the process-based quality management system model for ISO 13485 and the role of an internal audit in the maintenance and improvement of quality management systems.
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit, in accordance with ISO 19011.
3. Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 13485, and in accordance with ISO 19011.
Programme fee: €595 (€331 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
In registering for this course, each Learner must have the following prior knowledge before completing this course:
Management Systems
The Plan, Do, Check, Act (PDCA) Cycle
The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
ISO 13485
Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.
April, June, August, 2024. Check website for current schedule.
This is a blended learning program, consisting of:
6 hours of online & self-paced modules (= 1 day training)
2 half day virtual classroom days (Practical Workshop)Mornings
Comply Guru offer industry-leading ISO Training, IRCA Certified Internal or Lead Auditor and Medical Device Regulatory Courses.
This CQI & IRCA Certified Blended ISO 13485:2016 Lead Auditor Course is ideal for anyone that wants to gain the knowledge and skills required to perform first, second and third-party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011 and ISO/IEC 17021
A At the end of this course, participants will be able to:
1. Explain the purpose of a quality management system, of quality management systems standards, of management system audit, of third-party certification and the business benefits of improved performance of the quality management system
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up a quality management system audit in accordance with ISO 19011, and ISO/IEC 17021, as applicable
3. Plan, conduct, report and follow-up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011, and ISO/IEC 17021, as applicable
Programme fee: €1,195 (€712 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
In registering for this course, each Learner must have the following prior knowledge before completing this course:
Management Systems
• The Plan, Do, Check, Act (PDCA) Cycle
• The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review and continual improvement.
ISO 13485
• Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
• Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.
If any Learner does not meet the above entry criteria, successful completion of Comply Guru’s Online ISO 13485:2016 Foundation Course will ensure that they meet the above prior learning requirements.
Programme running in May, June, July and August, 2024. Check website for current schedule.
This is a blended learning programme:
16 hrs of online & self-paced modules (= 2 days training)
4 virtual classroom days (Practical Workshops); 9:00 - 16:30 Exam on final day (via eAssessment)
Comply Guru offer industry-leading ISO Training, IRCA Certified Internal or Lead Auditor and Medical Device Regulatory Courses.
The Irish Medtech Skillnet is delighted to join MEDDEV Solutions in bringing you this programme to ensure compliance and quality through effective validation. Process validation and equipment qualification are core disciplines in regulated life sciences manufacturing to demonstrate product quality and compliance. This comprehensive 2-day course will give individuals a greater understanding of the requirements of regulations in the EU and US, plus practical examples of how to meet them.
Understand the key concepts of process validation and the associated benefits
Appreciate how process validation links with the product development process
Understand how ISO 13485, regulations and guidance (such as the IMDRF) applies to manufacturers of medical devices
Correctly Identify when a manufacturing process requires validation
Describe the elements involved in performing process validation from planning to execution
Explain how to apply a risk-based approach to process validation
Illustrate the importance of a validation master plan (VMP) and validation protocols
Apply concepts learnt to develop a comprehensive VMP
Understand the difference and purpose of installation (IQ), operational (OQ) and performance qualification (PQ)
Apply concepts learnt to develop IQ, OQ and PQ protocols
Define and create relevant acceptance criteria
Understand and apply common statistical techniques used in process validation
Programme fee: €1,100 (€704 after funding)
See Website for current schedule.
This training course has great value for anyone who needs an understanding of or is engaged invalidation activities. Audience learning level: Basic to intermediate
Established in 2017, Meddev Solutions has become a specialist in medical device and pharmaceutical training and consultancy. With our in-depth knowledge of regulatory and quality requirements we only use best practice methodologies throughout our training.
Based on the body of knowledge of the ASQ’s Certified Quality Engineer, this course is run by Global Business Institute Ireland, for Irish Medtech Skillnet in response to the acute shortage of qualified quality engineers in the Medical Device and other industry sectors. The course is comprehensive, practical and completely covers all aspects of quality engineering including QMS design, documentation, process validation, auditing, capability analysis, MSA, data visualization, statistical decision making and medical device reliability.
Learners become certified by demonstrating the following core competencies through work experience and passing the examination:
· Quality management and leadership - the philosophies and foundations of quality, its leadership principles and techniques, and proven communication skills.
· Develop the quality management system (QMS) – design, documentation, standards and guidelines, quality training and auditing, and the cost of quality (COQ).
· Design of products, processes, and services - classification of characteristics, verification and validation, and reliability and maintainability.
· Critical skills required to implement effective product and process control - acceptance sampling, material control, metrology, and measurement system analysis.
· Mastery of the quantitative tools and techniques that drive continuous improvement, from lean and corrective action to kaizen and Six Sigma.
· Ability to summarize data, draw statistical conclusions, analyse distributions, test hypotheses, perform capability studies, and design and execute experiments.
· Be fluent in risk management: its oversight, assessment, control, auditing, and testing
Programme fee: €3,500 (€2,625 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
You will have to provide evidence of work experience as follows:
· 3 years – Masters or doctorate.
· 4 years - Bachelor’s degree (level 7 or 8)
· 8 years - if you do not have a degree or diploma
7 September, 2024
The course material is available 24/7 in pre-recorded video format, and blended with six (6) interactive virtual classroom days and weekly, one hour, tutorials at 7pm. Format of this course is Blended Learning. The programme is 15 weeks, and includes six (6) online virtual Saturday Workshops 9:00-17:00.
Certification provided by American Society of Qualification (ASQ). ASQ Certifications are recognized as a mark of quality excellence in many industries.
The Certified Quality Technician analyses and solves quality problems, prepares inspection plans, procedures and instructions, performs audits and can apply fundamental statistical methods for statistical process control. This course is designed to cover all modules of the American Society for Quality’s Body of Knowledge (BoK) for the Certified Quality Technician examination.
This is a one-part, 100 question, multiple choice four hour exam and is offered in English only.
LA Certified Quality Technician will naturally go on to become a Certified Quality Engineer by taking a CQE course and certification exam. A CQE is among the top earners in the manufacturing industry and her certification is recognized globally.
Course Outline:
Programme fee: €2,500 (€1,875 after funding) includes manual and exam fee
7 September, 2024
You must have at least four years of higher education and/or work experience in one or more of the areas of the Certified Quality Technician Body of Knowledge. If you have completed a degree from a college, university, or technical school with accreditation accepted by ASQ, part of the four year experience requirement will be waived.
Certification provided by American Society of Qualification (ASQ). ASQ Certifications are recognized as a mark of quality excellence in many industries.
The global Medical Technology industry is a highly regulated industry, to ensure that medical devices are manufactured to the highest quality and safety standards. As such, Medical Technology companies have grown their regulatory affairs teams to meet the growing global regulatory demands. The Master's in Medical Technology Regulatory Affairs was developed specifically to enable regulatory affairs personnel in Medtech to understand the global regulatory landscape, and develop skills to address and prepare for the ever-changing environment of regulatory affairs. The programme design also develops complementary skill sets such as communication and research skills. The programme integrates legal principles, ethics and compliance issues.
Training takes place over typically two years, with two semesters per year. Participants will complete a dissertation during Year 2 of the programme. Upon successful completion of the programme, participants receive an MSc award at NFQ Level 9.
EU Medical Technology Regulatory Affairs (introduction and advanced)
US Medical Technology Regulatory Affairs (introduction and advanced)
Technical Report Writing
Global Medical Technology Regulatory Affairs
Clinical Evaluation
Quality Management System
Risk Management, Labelling, and Promotion
Design Assurance, Sterilisation and Biocompatability
Post Market Surveillance
Programme fee: €10,800 (€8,100 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
Open to students who have obtained a Level 8 primary degree in a science/engineering subject related to the life sciences. Previous or current experience in regulatory affairs (minimum 2 years) may be taken into account in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.
Training takes place over typically two years, with two semesters per year. Participants will complete a dissertation during Year 2 of the programme. Dates to be announced for September 2024.
This programme has been designed to meet the growing demands of companies in filling sterility assurance scientist and quality assurance operational roles. The impetus for the development of this specialist programme emerged from industry needs and the content has been developed in conjunction with a Sterility focus group comprised of industry sterility experts from Irish Medtech Association’s Sterility Forum.
The Postgraduate Certificate in Science in End-to-End Sterility Assurance will provide students with a detailed understanding of sterilisation methodologies applied to medical technologies in a range of contexts. The programme will cover topics such as industrial microbiology, biocompatibility and cleanroom operations. In addition to current practices, the programme will include content on global trends in new sterilization methods.
The objective of this Programme is to provide an introduction to the BioInnovate principles, based on Stanford BioDesign, for identifying, Assessing
Previous or current experience in sterility (minimum two years) will be considered in assessing entry qualifications for candidates with relevant Level 7 qualification with appropriate experience.
1. Candidates who have completed modules in cognate programme areas may also enter the programme and gain exemptions as determined by the Programme Committee in accordance with the partner Institutions guidelines.
2. Cases will be assessed on an individual basis by the Programme Committee.
3. 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.
4. Prior experiential learning will be assessed using guidelines recommended by the Academic Council of ATU Galway.
6.
5. Places are subject to approval by ATU Galway.
Programme fee: €4,500 (€3,375 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
Learners will develop detailed knowledge of the regulatory requirements for sterilisation and the ability to source, interpret and apply standards for conformity. The programme will be delivered by both academics and key industry experts through a flexible blended approach, with induction taking place onsite in ATU. Lectures will be delivered online with practical demonstrations to be delivered at the later stages of the programme.
9th January 2024 - 31st December 2024
1 Year
ATU is a multi-campus technological university in the west and northwest of Ireland that delivers a rich combination of academic and research excellence, quality of life and opportunity.
The Master of Science in End-to-End Sterility Assurance programme is aimed at graduates who have either a science or bioengineering background and are aiming to develop their careers in sterility assurance. The programme aims to develop an in-depth knowledge/understanding of Sterility assurance methodologies for medical technologies in a range of contexts. Innovation in sterility assurance for medical technologies, including new techniques and global trends in technology and sustainability. Concepts of industrial microbiology in controlled settings. Principles of biocompatibility and biological evaluations for sterility assurance. Report writing, analytical, and problem-solving skills for a lifelong career in sterility assurance. Executive leadership strategies and advanced methodologies for managing innovation to drive business growth. Learners will develop advanced skills in research and the ability to interpret and implement regulations and quality standards for conformity within the Medtech sector. This programme builds on the recently developed Postgraduate Certificate in Sterility Assurance and has the support of a large number of indigenous and multinational-based companies and will be delivered through a flexible blended approach.
The objective of this Programme is to provide an introduction to the BioInnovate principles, based on Stanford BioDesign, for identifying, Assessing
Open to students who have obtained a L9 Postgraduate Certificate in End-to-End Sterility Assurance.
- Medical Device Product life-cycle
- Design of Experiments & Analysis
- Research Methods
- Leadership and Teams
- Managing Innovation
- Medical Device Product Life Cycle
- Applied Research Project
Programme fee: €5,500 (€3,500 after funding)
NEXT COURSE STARTING
September 30th, 2024
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
1 Year. Blended learning online and on campus at ATU Galway.
ATU is a multi-campus technological university in the west and northwest of Ireland that delivers a rich combination of academic and research excellence, quality of life and opportunity.
*This programme is funded under Skills Connect and is for people who are currently seeking employment, subject to eligibility criteria*
If you are currently not in employment and you are looking to reskill/upskill and prepare for entry into the workforce, then this course is for you. The training programme is designed to enhance participants skills in finding work.
The CPD Special Purpose Award Certificate in Career Readiness is to give the participants a range of vital skills and knowledge which employers look for and value in recruiting new staff to their organisations. The course focuses particularly on applying the skills in the world of work, aiming to build both competence and confidence in a range of critical areas.
Specifically, the course aims to develop participants’ skills to empower them to succeed in managing their careers and finding work.
To increase their self-confidence and their ability to put their best foot forward in a job interview.
To understand their personal behaviour style and its impact on others and to generally increase their selfawareness and awareness of others.
To be able to manage their time and effectively and to behave assertively.
Also to develop and work on a personal action plan to increase their success at finding work and in developing their careers.
Starts FEBRUARY 2024 Register Interest Now
DATES AND DURATION
April 26th, 2024
Exploring Essential BioDesign Principles to Drive Health Technology Innovation.
The objective of this Programme is to provide an introduction to the BioInnovate principles, based on Stanford BioDesign, for identifying, innovating and assessing health technology opportunities. The Programme will emphasise the tools, language and philosophy of the process of innovating health care solutions while minimising the risk of project or commercial failure.
The Programme will combine content delivery, case studies and applied problem-based learning methods to give perspectives and visibility on the process of innovating a novel health technology. This Programme is targeted at companies who are considering an investment in innovation and want their team to embrace the BioInnovate process for innovating health technologies.
The objective of this Programme is to provide an introduction to the BioInnovate principles, based on Stanford BioDesign, for identifying, Assessing
On completion of this Programme the learner will/should be able to:
1.
2.
Demonstrate awareness of the process for innovating medical technologies.
Demonstrate awareness of how to identify an important unmet medical need taking into consideration clinical, scientific and market knowledge.
3.
Appreciate the holistic view of the BioInnovate process including a broad understanding of the considerations and stakeholders involved in bringing a new innovation from a healthcare problem to a commercial solution.
4.
Demonstrate effectiveness in presenting the unique problem to be solved.
5. Communicate the value proposition of a concept.
Demonstrate effectiveness in developing filtering criteria for clinical needs.
6.
Programme fee: €3600 (€2,268 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
This Programme is suitable for a broad range of disciplines including, R&D Engineers, Software Engineers and Data Scientists; Quality and Regulatory affairs professionals; Marketing and Post-market surveillance professionals; Healthcare Professionals and beyond.
27 - 29 March 2024
(Spaces are limited)
3 Days
Affiliated with Stanford University’s globally renowned BioDesign program, BioInnovate Ireland has a proven track record in training and supporting the next generation of global entrepreneurs, Medtech experts and healthcare leaders.
5-Day Preparation Course for the PMP® certification e am
COST Programme fee: €6,000 (reduced to €3,780 with Irish Medtech Skillnet funding)
The Senior Leaders programme is a 3 day residential leadership programme delivered by BlueLake High Performance Partners in conjunction with the University of Limerick and Munster Rugby. Taking place on the University of Limerick Campus in the Munster Rugby High Performance Centre on the 28th, 29th and 30th of May 2024.
5-Day Preparation Course for the PMP® certification exam.
Project Management Professional (PMP)®The Project Management Professional (PMP®) certification is the most widely recognised certification available to Project Managers worldwide. Velopi’s PMP® exam preparation course supports you from the PMP® application process right through to success at the PMP® certification exam.
This course provides a detailed exploration of the syllabus and will explain the exam policies and procedures. Using sample exams covering the core exam material you will be exposed to questions having the same format as those in the actual exam. You will get post-course support from the PMP® certified tutor and have unlimited access to Velopi's exam simulator which provides full trial exams to ensure you are well prepared to pass the PMP® exam.
Suitable for Project Managers and other individuals preparing to take the PMP® exam and seeking expert guidance on exam strategy, hot topics, sample exam questions and after-course support to ensure they obtain the PMP® certification.
• Revise all core PMP® exam content and hot topics
• Identify and recognize the various types of PMP® exam questions
• Complete sample exams using our PMP exam simulator
• Assemble an exam checklist allowing easy recall of mathematical formulas that appear on the exam
• Compile an exam strategy that will be used in the actual exam
• Become familiar with the exam policies and procedures
• Meet the 35 hour Project Management training requirement for the PMP application
Programme fee: €1,195 (€777 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES COST
This PMP exam preparation course is delivered online via Zoom. Starts October 2nd, 2024.
Velopi is a ProjectManagementInstitute(PMI)® Authorized Training Partner(ATP), which ensures you are learning “PMI®-developed” PMP® exam preparation material.
This programme is specifically designed for holders of a Bachelor of Engineering( B.ENG) in Manufacturing Engineering (level 7), working in the manufacturing industry and wishing to up-skill with the aim to support their organisation in the transition to Industry 4.0.
As part of the progression route for employees, delivered through Atlantic Technological University (ATU) Galway, the one year B.Eng. (H) in Advanced Manufacturing Systems (Level 8) is an innovative programme designed in close consultation with the manufacturing industry who have identified a requirement to upskill their employees.
This one year programme offers a progression route for level 7 Manufacturing Engineers (or related discipline) who wish to progress into advanced manufacturing.
Runs over 52 weeks, including two semesters of 17 weeks of tuition and an Industry project. Students attend two evenings of online classes per week with 8 on-site days at ATU Galway including Induction and Examination.
The B.Eng. in Advanced Manufacturing Systems aims to up-skill mature learners working (or having worked) in the manufacturing industry from a level 7 to a level 8. Taking into consideration their background and work situation, the programme is designed to take advantage of this prior or/and current experience to allow flexibility in their learning while minimising the requirement for face-to-face interaction with their lecturers.
The entry requirement for the programme is a B.Eng. in Manufacturing Engineering or related discipline with a minimum of one year experience in the manufacturing industry. As the Industrial engineering project is an applied project to be conducted in industry, applicants should either be employed or have an agreement with a company that will allow them to conduct their project in their manufacturing facilities.
COST
Programme fee: €6,000 (€4,500 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
One-Year Programme, delivered part-time to allow flexibility to people who wish to upskill while continuing to work Starts September16th, 2024.
ATU is a multi-campus technological university in the west and northwest of Ireland that delivers a rich combination of academic and research excellence, quality of life and opportunity.
The programme covers essential elements of digitalisation of manufacturing and their application in practice. The goal of the master's is to provide an expert level appraisal of relevant technologies, tools and techniques in a range of relevant disciplines, so that the Learner can assess current trends, engage with specialist professionals, and identify the potential benefits of digitalisation of manufacturing and embracing industry 4.0.
Credits towards the 2-Year Masters Programme can also be earned through our Micro-Credentialing process whereby candidates can attend one or more stand alone modules in response to a specific business need, or with the intention of gradually completing the full programme on an extended schedule.
The modules include:
Database Design & Data Visualisation *
Cyber-Physical Systems & IoT *
Manufacturing Automation & Robotics
Data Analytics & Machine Learning
Integrated Database Systems
Digitalisation of Production
* Can be booked as a stand-alone module.
All of the modules are integrated with work-based practice and are supported by regular online tutorials. The completion of an applied research project will bring significant advances in terms of professional and personal development, communication skills and confidence to present proposals and results.
Principal entry requirement - Level 8 honours degree, at minimum second class honours (NFQ or other internationally recognised equivalent), in a relevant engineering, computing, or technology discipline. Holders of other Level 8 degrees with a minimum of five years experiential learning in an appropriate manufacturing environment (demonstrating knowledge of mathematics and computing) may also apply.
COST
Programme fee: €10,000 (€7,500 after funding)
THIS PROGRAMME IS FUNDED FOR ORGANISATIONS OF ALL SIZES. ADDITIONAL DISCOUNTS AVAILABLE TO START-UPS/SMES
Two-Year Programme, structured into the following: Two mandatory boot camps . Each boot camp is 4 days (Wed - Sat). Four optional workshops. Each workshop is 2 days (Fri - Sat). Dates to be announced for November 2024.
TUS is a multi-campus university with a strong and vibrant history of education and learning in the wider region.
