Building Regulatory & Technical Capability
Health Software · AI-Enabled Medical Devices · EU MDR/IVDR
UK MDR · QMSR · AI
Act · Standards
Drawing on 30+ years in medical devices — including experience as a Notified Body technical reviewer and site auditor, and work with organisations such as Boston Scientific, J&J, Abbott, and Medtronic — I deliver targeted training programmes that equip industry teams with practical, up-to-date knowledge of the regulatory landscape for AI-enabled medical devices.
IEC 62304 Essentials — Free Online Course
A free self-paced course covering all 13 IEC 62304 process areas at two levels — an Introductory level for those new to the standard, and an Advanced level with full clause references for experienced practitioners. Study at your own pace, then test your knowledge with a timed 15-question assessment. Score 80% or higher to download a certificate of completion.
13 Process Areas, Two Levels
Introductory content for those new to IEC 62304 and full clause-referenced Advanced content for experienced practitioners — switch level at any time, filterable by safety class.
Timed Quiz
15 multiple-choice questions with immediate feedback. Separate Introductory and Advanced question sets align with the level you studied at. 60 seconds per question.
Downloadable Certificate
Score 80% or higher and download a certificate of completion — useful for CPD records and team training evidence.
IEC 62304 Edition 2
The next edition of IEC 62304 is under active development at IEC TC62. Key proposed changes include:
- Expanded scope to cover health software broadly, aligning with IEC 82304-1
- Two Software Process Rigor Levels replacing the three safety classes (A, B, C)
- Softened normative references to ISO 13485 and ISO 14971
- Legacy software provisions moving to an informative annex
Training updated for Edition 2 will be published here as the standard is finalised. This course reflects the current published standard: IEC 62304:2006+AMD1:2015.
Training Programmes for Industry
Each programme is designed for regulatory affairs, quality, and engineering professionals working on medical devices — combining regulatory theory with practical application and the latest developments from standards committees and doctoral research.
Navigating the AI Act for Medical Device Manufacturers
A practical introduction to EU AI Act obligations for manufacturers of AI-enabled medical devices — covering high-risk AI system classification, Article 22 requirements, conformity assessment routes, and interaction with EU MDR 2017/745.
AI/ML Software Lifecycle for Medical Devices
Practical training on IEC 62304 software lifecycle requirements as applied to AI/ML-enabled devices — addressing adaptive algorithm change management, post-market surveillance obligations, and risk management under ISO 14971.
AI Governance Frameworks in Practice
Workshop-based training on implementing AI governance in a medical device organisation — using ISO 42001 and BS 30440:2023 as practical frameworks alongside the ChangeIQ methodology developed through doctoral research.
MDR Compliance for AI-Enabled Devices
In-depth training on EU MDR 2017/745 obligations specific to software and AI-enabled medical devices — including technical documentation requirements, PMCF obligations, and the implications of the EC Simplification Digital Package.
Emerging Standards Briefing
A regularly updated briefing programme on the current and emerging standards landscape for AI-enabled medical devices — drawing directly on active participation in IEC TC62, NSAI/ETC/TC10, and CEN-CENELEC AI Task Groups 1 & 2.
Custom In-House Training
Tailored training designed around your organisation's specific regulatory context, product portfolio, and team needs. Suitable for regulatory, quality, and R&D teams at any stage of MDR or AI Act readiness.
Medical Device & IVD Software — Modular Training Programme
A menu of focused sessions on the regulation, standards, and quality management of Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Clinical Decision Support Systems (CDSS), and in-vitro diagnostic (IVD) software. Each session runs two hours and can be delivered online or on-site. Sessions are modular — select the topics most relevant to where your organisation is in development, in any combination. Session 1 is the recommended foundation and is included as a minimum, as it provides the regulatory and standards grounding the other sessions build on; the remaining sessions can be chosen freely.
| # | Training Session | Key Standards & Frameworks | Select |
|---|---|---|---|
| 1 | Regulations & Standards Overview for Medical Device & IVD Software
Recommended Foundation
The regulatory landscape and core standards for software that is, or is part of, a medical device or IVD — the essential grounding for every other session. |
EU MDR 2017/745 · EU IVDR 2017/746 · FDA SaMD · IEC 62304 · ISO 14971 · ISO 13485 | |
| 2 | What is SaMD? Qualification & Classification
Determining whether software qualifies as a medical device and how it is classified across the EU and FDA frameworks. |
IMDRF SaMD framework · MDCG 2019-11 · MDR Rule 11 · FDA SaMD categories | |
| 3 | IVD Software — Qualification, Classification & Specifics
How software is qualified and classified under the IVDR, including software that drives or influences an IVD, companion diagnostics and accompanying software. |
EU IVDR 2017/746 · MDCG 2019-11 · IVDR classification rules | |
| 4 | Clinical Decision Support Systems (CDSS)
When clinical decision support qualifies as a medical device and when it does not — the criteria that distinguish device CDS from exempt decision support, and the obligations that follow under the EU and FDA frameworks. |
FDA CDS guidance (2022) · MDR Rule 11 · MDCG 2019-11 · IMDRF SaMD | |
| 5 | Software Development Lifecycle — IEC 62304
The software lifecycle processes and software safety classification (Class A/B/C), and how they shape your development plan. |
IEC 62304 · IEC 82304-1 | |
| 6 | Software in a Medical Device (SiMD) & Medical Electrical Equipment
Where software is embedded in medical electrical equipment (SiMD rather than SaMD): how IEC 62304 interfaces with the IEC 60601 series, including programmable electrical medical systems (PEMS) and the related risk and usability collateral standards. |
IEC 60601-1 (Clause 14, PEMS) · IEC 60601-1-x collaterals · IEC 62304 | |
| 7 | Software Risk Management
Applying ISO 14971 to software — identifying how software can contribute to hazardous situations and designing effective risk controls. |
ISO 14971 · ISO/TR 24971 · IEC 62304 (risk) | |
| 8 | Software Requirements & Architecture
Eliciting and managing software requirements and defining architecture and detailed design with traceability through the lifecycle. |
IEC 62304 · requirements & architecture practice | |
| 9 | Verification & Validation of Software
Building a V&V strategy — unit, integration and system testing, test management and traceability to requirements and risk. |
IEC 62304 · FDA software validation / CSA | |
| 10 | SOUP, Off-the-Shelf & Open-Source Software
Managing software of unknown provenance, third-party and open-source components, including the software bill of materials (SBOM). |
IEC 62304 (SOUP) · SBOM · FDA OTS guidance | |
| 11 | Software Configuration & Change Management
Version control, configuration items, change control and problem resolution across the software lifecycle. |
IEC 62304 §§6-9 · ISO 13485 | |
| 12 | Cybersecurity for Medical Device & IVD Software
Pre- and post-market security across the lifecycle — threat modelling, secure development and vulnerability management. |
IEC 81001-5-1 · MDCG 2019-16 · FDA premarket cybersecurity | |
| 13 | Usability & Human Factors Engineering
Usability engineering and use-related risk for software interfaces, including formative and summative evaluation. |
IEC 62366-1 · IEC 62366-2 · FDA HFE guidance | |
| 14 | Health Software & Health IT
Standalone health software, mobile and cloud/SaaS delivery, and product-level safety considerations beyond the device itself. |
IEC 82304-1 · IEC 80001-1 (health IT networks) | |
| 15 | Interoperability & Data Exchange
Connecting software safely — clinical and laboratory data exchange, and the standards that underpin interoperability. |
HL7 FHIR · DICOM · IEC 80001-1 · LIS/LIMS connectivity | |
| 16 | Clinical Evaluation & Performance Evaluation for Software
Generating the clinical and performance evidence expected for software, and how the requirements differ between the MDR and IVDR. |
MDR clinical evaluation · IVDR performance evaluation · MDCG guidance | |
| 17 | IVD Performance Evaluation
Scientific validity, analytical performance and clinical performance for IVD software, and structuring the performance evaluation plan and report. |
IVDR Annex XIII · ISO 15189 context · CLSI guidance | |
| 18 | Quality Management System for Software Teams
Applying ISO 13485 and design controls to software development, including how agile fits within a compliant QMS. |
ISO 13485 · FDA design controls (QMSR) · AAMI TIR45 (agile) | |
| 19 | Technical Documentation & Conformity Assessment
Compiling MDR/IVDR technical documentation for software and what to expect from Notified Body review. |
MDR Annex II/III · IVDR Annex II/III · Notified Body review | |
| 20 | Post-Market Surveillance, Maintenance & Vigilance for Software
Post-market obligations for software — surveillance, maintenance, updates and patches, and incident reporting. |
MDR/IVDR PMS · PMCF/PMPF · software maintenance & vigilance |
AI-specific modules — AI governance, AI Act compliance, and AI risk management — are available separately as part of the AI in Medical Devices programme below. Download the full programme as a PDF.
AI in Medical Devices — Modular Training Programme
A menu of focused sessions on the regulation, standards, and quality management of AI-enabled medical devices — complementing the Medical Device & IVD Software programme above for organisations that need both software-lifecycle and AI-specific training. Each session runs two hours and can be delivered online or on-site. Sessions are modular — select the topics most relevant to where your organisation is in development, in any combination. Session 1 is the recommended foundation and is included as a minimum, as it provides the regulatory and standards grounding the other sessions build on; the remaining sessions can be chosen freely.
| # | Training Session | Key Standards & Frameworks | Select |
|---|---|---|---|
| 1 | Regulations & Standards Overview and Trustworthy AI in Healthcare
Recommended Foundation
The full regulatory landscape for AI-enabled medical devices and the principles of trustworthy AI — the essential grounding for every other session. |
EU MDR 2017/745 · EU AI Act (Reg. 2024/1689) · FDA SaMD · IEC 62304 · ISO 14971 · ISO 13485 · ISO/IEC 42001 | |
| 2 | Introduction to AI — Overview of AI Model Types
Core AI/ML concepts for regulatory, quality and engineering teams, with emphasis on the model types most relevant to medical devices — for example convolutional and vision models for imaging applications, and pre-trained/foundation models. |
Foundational — no single standard | |
| 3 | AI Management System (e.g. ISO/IEC 42001)
Establishing an AI management system and integrating it with an existing ISO 13485 quality system rather than running it in parallel. |
ISO/IEC 42001 · ISO 13485 | |
| 4 | Pre-Trained Models and Evaluation
Evaluating externally sourced and pre-trained models for safety, bias and regulatory acceptability — drawn directly from peer-reviewed published research. |
ISO 14971 · EU AI Act · supporting evaluation frameworks | |
| 5 | Deep Dive into an Example AI-Enabled Device
A worked walkthrough of an example AI-enabled device from concept through to evidence — connecting regulatory theory to a concrete development case (illustrated here with an imaging application, optionally using a modelling tool such as Neural Designer). |
Applied — integrates IEC 62304 / ISO 14971 | |
| 6 | AI Risk Management
AI-specific hazard identification and risk control across the device lifecycle, including data, model and performance-drift hazards. |
ISO 14971 · ISO/TR 24971 (AI risk guidance) | |
| 7 | Software Functions for AI — FDA
The FDA approach to AI/ML software functions and Software as a Medical Device, and how it differs from the EU route. |
FDA SaMD guidance · 21 CFR Part 820 / QMSR | |
| 8 | Software Development Lifecycle & Agentic AI
Applying the software lifecycle to AI/ML components, including IEC 62304 Edition 2 developments and considerations for agentic AI. |
IEC 62304 (incl. Ed.2 developments) | |
| 9 | Predetermined Change Control Plans / Monitoring Plans
Designing PCCPs and monitoring plans so adaptive or updatable models can be maintained without re-triggering full conformity assessment. |
FDA PCCP guidance · EU change-management expectations | |
| 10 | EU AI Act 2024/1689 (as amended) + MDCGs
High-risk AI system obligations, the interplay with EU MDR, and emerging MDCG guidance, reflecting the latest amendments and the EC Simplification Digital Package. |
EU AI Act (Reg. 2024/1689) · EU MDR · MDCG guidance | |
| 11 | AI Data Management
Dataset governance, quality, representativeness and bias — including annotation and labelling provenance. |
IEC PAS 63621 · ISO/IEC 42001 | |
| 12 | AI Data Management — PAS, Example Plan & Report
A practical, worked example of a data management plan and the corresponding report, using the structure of the data-management PAS. |
IEC PAS 63621 (worked example) | |
| 13 | AI Test Methods & Metrics
Verification and validation methods and metrics for AI, including cross-validation and the test-method approaches now emerging in standards. |
IEC 63450 (in development) · V&V methods | |
| 14 | AI Security Risks and Mitigations
Cybersecurity for AI-enabled medical devices — threat modelling, SBOM, and mitigation across the lifecycle. |
IEC 81001-5-1 · EU MDR security requirements | |
| 15 | AI in PEMS — IEC 60601-4-1
AI within programmable electrical medical systems and the concept of degree of autonomy, where the device is also electrical medical equipment. |
IEC 60601-4-1 · IEC 60601-1 | |
| 16 | AI Usability & Human Factors
Usability engineering for AI-enabled devices, including how clinicians interpret and act on AI output. |
IEC 62366-1 · IEC 62366-2 · emerging IEC 62366-3 (AI) | |
| 17 | Performance Evaluation
Analytical and clinical performance evaluation for AI — sensitivity, specificity and AUROC, and standalone versus reader-study designs. |
Performance evidence aligned to EU MDR / FDA expectations | |
| 18 | Post-Market AI Requirements, Maintenance & Change Management
Post-market surveillance obligations specific to AI/ML, ongoing maintenance, and managing change in deployed models. |
EU MDR PMS · EU AI Act · post-market ML surveillance |
Sessions can be tailored to your organisation's specific device type and reduced to one hour each, completed over 9–10 sessions, if preferred. Download the full programme as a PDF.
Flexible Delivery Formats
Training is available in a range of formats to suit your organisation's needs, from half-day workshops to multi-session programmes — delivered online or on-site.
Half-Day & Full-Day Workshops
Focused, intensive sessions designed for regulatory and quality teams who need actionable knowledge quickly. Available as standalone workshops or as part of a series.
Multi-Session Training Programmes
Structured programmes delivered over several sessions, building regulatory capability progressively — suitable for onboarding new team members or upskilling an existing team ahead of MDR or AI Act obligations.
Remote & In-Person Delivery
All programmes are available online or in person. On-site delivery can be arranged across Ireland and the EU. Remote delivery is available globally.
Tailored to Your Context
Content and case studies are adapted to your organisation's device portfolio, regulatory status, and team background — ensuring training is directly applicable to your real-world challenges.
Upcoming Public Training Sessions
The following sessions are planned for open enrolment. Places are limited — contact me to register interest or to discuss in-house delivery on a preferred date.
| Training Programme | Planned Date | Format | Duration | Delivery | Status |
|---|---|---|---|---|---|
| Change Management for Regulatory Affairs | November 2026 | TBC | TBC | With Leap Compliance | Confirmed |
| MDR Compliance for Software & AI-Enabled Devices | TBC 2027 | Programme · 2 sessions | 2 hours each | Online / On-site | Planned |
| Emerging Standards Briefing — IEC TC62 Update | TBC 2027 | Briefing | 2 hours | Online | Planned |
| IEC 62304 Ed. 2 — Software Life Cycle Processes | TBC 2027 | TBC | TBC | Online / On-site | Planned |
| AI Validation for Life Sciences | TBC 2027 | TBC | TBC | Online / On-site | Planned |
Dates are indicative and subject to confirmation. to register interest or arrange bespoke in-house delivery.
Postgraduate Lecturing at DkIT
Alongside doctoral research, I lecture on one postgraduate module per term at Dundalk Institute of Technology at MSc Level 9 — covering healthcare software engineering, security, usability, and research practice.
Software Development and Validation in Healthcare
COMP_C9045 — Covering software development lifecycle processes and validation requirements for healthcare software, including IEC 62304 and regulatory compliance frameworks.
Further Modules
- Security in Healthcare
- Usability Engineering
- Research Methods
- Embedded Systems
- Healthcare Informatics
- Software Testing & Validation
- Medical Device Software Regulations
- AI in Healthcare
- Data Mining and AI
What Training Participants Say
Responses from a recent SaMD Software Development training programme, covering regulations, standards, software risk management, SOUP, and post-market surveillance.
“The trainer explanations and discussions were the most helpful part of the course — it was useful to all parts of my role, especially when focusing on clinical evidence generation.”
Julie Murdoc, Clinical
“The most valuable outcome was realising the importance of following regulations and being able to pass audits for the future of the company.”
Phillip Eccles, Technical
“This course grounds us and gives us the bigger picture, that we're not just shipping software, we're building a regulated medical device where the choices we make in code carry real clinical and patient safety implications. It's given me a much clearer sense of why the risk management, documentation and postmarket work actually matter, rather than feeling like box ticking, and how our day-to-day engineering decisions feed straight into that.”
Rona Clancy
Discuss a Training Programme for Your Team
Whether you are preparing your team for EU MDR compliance, building AI governance capability, or seeking an expert briefing on emerging standards, we welcome a conversation about how training can support your organisation.
