The aim of this module is to introduce students to the Regulatory Affairs profession. It provides an initial introduction to the key regulatory concepts and the primary module topics of the programme. Each week students will explore a key regulatory topic which will become the main subject of in-depth learning within a few weeks or in Semester 2. As an example, the significane of a quality management system will be examined on week 2 with students delving into the context and application of a QMS in detail commencing in week 4.

This methodology helps students to gain perspective on the regulatory framework from the outset and the proficiency to compartmentalize the global regulators and associated sanctions they can impose. This approach also mimics a medical device lifecyle and induction to the key processes such as risk, design & human use clinical evaluation will augment the educational experience. As students acquire a degree of knowledge on the key regulatory topics this will prepare and encourage them to contemplate and engage as a regulatory professional throughout the programme.

The regulatory affairs professional is critical to making safe and effective medical products available to patients worldwide. These professionals ensure compliance with international medical device regulations for safety and efficacy. Regulatory Affairs is one of the most in-demand professions in the medical technology industry in Ireland and beyond.

National Regulatory Bodies & Industry Leaders guest speakers will emphasise the significance of the role to students through live presentation & pre-recorded media. The primary tutors who introduce each of these subjects initially will be expanding in later in-depth modules.

1. Identify and illustrate the medical technology global regulatory framework, outline the regulations and regulators. Compile and conclude the key elements that influence regulatory strategy from a product lifecycle context i.e. the QMS system applicable to regulatory jurisdiction and device classification

2. Explain the relevance of the EU,U.S. and other major Global Regulations for the RA Professional including an understanding of the differences and influence of key market Regulators. Justify and critique the appropriate market application process to match the device classification.

3. Develop initial regulatory processesfor the business and analyse device changes to ensure they meet regulations. Evaluate the role of Design, Risk Management and Clinical studies in the overall regulatory context and assess post market experience for inclusion.

4. Demonstrate anunderstanding ofthe concepts underpining the implications of medical device safety monitoring post release includingVigilance and Post Market Surveillancereporting.

5. Compare and contrast regulations and select the minimum businessapplications required to establish appropriate, consistent and practical procedures and policies for the industry.

The objective of this module is to ensure that students understand the role and application of a Quality Management System, Regulatory Strategy and auditing concepts as they relate to the regulatory affairs profession. An overview of the key standards and regulations as they apply to regulatory strategy and audits will be achieved along with the ability to create the framework to establish, maintain and implement a QMS.

Regardless of where a medical device is planned to be sold, the Legal Manufacturer must first implement a suitable Quality Management System to meet the business and regulatory requirements. Depending on the medical device classification and the planned market, the level of controls can vary. This module will provide learning on the key QMS models that must be met and are globally recognized. Audit preparation and regulator interactions will be explored and experiences shared to deliver acceptable outcomes.

1. Evaluate and Identifyanappropriate QMS applicationto meet the regulatory business strategy and plans formarket.Develop a QMS in line with ISO 13485:2016 standard and explainit’s significance from a global regulatory perspective.

2. Compare and contrast the U.S.requirements underCFR part 820and the globally recognizedISO 13485:2016 standard.

3. Design a QMS in line with device classifications and regulatory expectations, from general controls to full compliance.Demonstrate ability to create relevant QMS documents, including Quality Manual, Standard Operating Procedures, Work instructions andtemplates for a clean room environment.

4. Determine the expectations for regulatory body inspectionsand identifythe QMS documentation to support certification inspections and device approvals.

5. Explain theregulatory role within the overall business context.Identify and source regulatory intelligence to ensure the team and business are well informed and QMS systems adapt to ongoing changes and expectations as necessary.

This module will provide in-depth learning on design control processes in the research phase and application of risk management analysis working towards the fulfilment of a clinical investigation. A thorough evaluation of the design control methods, testing and validation processes will be explored. Suitable manufacturing processes and cleanroom validation will be examined by device category. A thorough review of risk analysis and risk management concepts will be evaluated especially in the context of the medical device life-cycle.

Clinical Studies on medical devices are critical to demonstrate safety & efficacy and mandatory for the manufacturer. This module will take students through the different types of studies, the relevant research stages and provide a thorough understanding of the key stakeholders and deliverables involved. The regulatory professional is a key contributor to the clinical study process and must have the ability to engage professionally and competently with Authorities.

1. Identify and interpret therelevant EU, U.S. regulations, guidance and applicable standards for Device Design, Risk Managementand Clinical study phases.

2. Explain and justify thedesign, testing andmanufacturing transfer processes along withthe cleanroom validation expectations that impact regulatory inputs in technical filesfor medical devices.

3. Critiquerisk analysis in line with regulations and relevant standards including ISO 14971 proportionate tothe device classification.Determine the designreview stages and compilethe corresponding market applications.

4. Demonstrate competency in the Clinical evaluationprocess to ensure that the key regulatory and business deliverables are achieved.

The aim of this module is to ensure that participants recognise and understand the requirements and are competent in application methods and processes to achieve approval or clearance for medical devices in the U.S. The FDA is the mandated regulatory body responsible for medical device approval & clearance for the U.S. market. Students will benefit from interaction with tutors who have worked in the U.S. and dealt directly with the FDA. This first-hand knowledge will help students to understand the processes and penalties for this region.

The ability to deliver the contents of a Pre-market approval or 510(k) application will be a desired deliverable.

1. Describe and apply the principle requirements for route to U.S. market for medical devices. Evaluate and conclude the relevant submission content for a PMA or 510(k) clearance. Justify the ‘substantial equivalence’ rule based on device classification. Substantiate the benefit of the ‘third party’ review process.

2. Develop U.S. Regulatory strategy incorporating defined FDA timelines to include pre-submission meetings, predicting likely internal & external obstacles. Assess and justify suitable file structure and content to meet 510(k) and PMA applicaiton requirements.Distinguish between the CDRH role, office of device evaluation & compliance oversight functions.

3. Evaluate and complete device changes post release to determine thechange classification, compile substantial change notifications in line with supplements, 30 day notices or other relevant filing mechanism.Interpret the rules and extrapolate the technical data required to fulfill FDA submission questions.

4. Indicate and illustrate theuse of FDA guidance and consensus standards and incorporate into regulatoy business systems. Demonstrate competence in use of theFDA.GOV website to ensure currenct concepts and expectations are achieved and vast education sources are considered.

The aim of this module is to allow participants to become competent in the regulations that govern Medical Devices in the EU market. Especially new regulations recently introduced: 2017/745 (MDR) &/or In-vitro Diagnostics 2017/746 (IVDR). A medical technology manufacturer must obtain CE mark with certification to place a device on the market. In conjunction with this process, they must declare that they will conform with the relevant European regulations post release to ensure continued compliance.

In addition to the introduction of new regulations for Europe, the arrangements for the U.K. market exit will be explored. It will be imperative that students understand the significance that such variations involve for the regulatory professional and the medtech sector.

1. Evaluate the key differences introduced in the new European regulations and identify thebusiness impact and recommend steps to be taken forMedical Devices & Invitro Diagnostics.

2. Describe the current European Regulatory framework and demonstrate competency in knowledge of key regulators.

3. Demonstrate competency in the key CE marking processes.Differentiate and formulate the relevant technical documents required for CE approval.

4. Prepare key procedures and templatesto support European regulatory strategy and ensure consistent application and delivery.

5. Evaluatecommon specifications, guidance documents, standards relevant to CE marking process and regulatory intelligence sites.

A critical analysis will be undertaken on the regulatory and legal framework of other key global regulators other than the U.S. & EU to implement necessary policies and procedures for medical device approval and market sustainability. The significance of expanding regulatory geographies will be examined, and the commonalities identified to ensure students understand the critical documents and build global regulatory files.

The aim of this module is also to ensure that students can build a regulatory intelligence matrix to accommodate global regulatory filings, device changes and regulatory inspections, including the Medical Device Single Audit Programme 'MDSAP'.

1. Implement the regulatory requirements necessary to obtain medical device approval in all other major markets other than U.S. & Europe, including the processes required to achieve Medical Device Single Audit Process (MDSAP) application and certification.

2. Develop regulatory processes to keep devices up todate in the market with associated timelines & address device changes as appropriate. Design and validate a suitable regulatroy intelligence matrix which provides business clarity for all relevant markets.

3. Compile technical files, design dossiers, Shonin’s & STED documentation in line with country specific mandates e.g. Japan – Shonin, Canada & Australia – Technical files etc.

4. Inform the business on the regulatory & postmarket expectations for the global regulatory regions to ensure adequate implementation & compliance.

The aim of this module will cover the business and ethical responsibilities of a company following placing a medical device on the market. The critical regulatory systems and processes which must be in place to protect patients and users. It will include the interaction between regulators and industry in the post market phase of the medical device. Students will be competent in the use of regulatory body databases and practise sample input. The appropriate tools for vigilance decision-making and safety report filing will be examined for the relevant global jurisdictions. Understanding the management and implementation of field safety actions will be evaluated.

1. Evaluate the legal requirements relating to postmarket surveillance,vigilance and similiar reports types to ensure regulatorycompliance is achieved.

2. Describe the current global requirements for medical device event reporting in line with risk level of the device.

3. Prepare incident reports for the relevant authorities,inputthe appropriate data toEudamed or Maude databaes or corresponding submissionsfor other regions.

4. Demonstrate competency in complaint and sales data analysis to appropriately presentevent rate occurrence.

5. Implement business processes to communicate safety related field actions ethicallyi.e. recalls. in line with regulations.