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Management Forum

Medical Device Software: Complying with the EU (European Union) MDR (Medical Device Regulation), EU (European Union) IVDR (In-Vitro Diagnostic Regulation) & FDA (Food and Drug Administration) Regulations Training Course

An introduction to medical device software regulations and requirements to include the latest EU and FDA guidance and risk management.

26-30 January 2026
+ 22-26 June 2026 »
from £2199

Need help? Enrol/reserve

Course overview

Master the critical decisions that shape your software’s regulatory success. Every choice you make, from product claims to technology selection and regulatory positioning, can determine the outcome of your market authorisation process. Missteps can mean costly delays, increased development expenses and even denied market entry. This course gives you the clarity and confidence to avoid these pitfalls and ensure your innovation achieves its full global potential.

With emerging technologies such as digital therapeutics, machine learning and cloud computing, navigating the regulatory landscape has never been more complex. Distinguishing medical from non-medical software, defining clinical validation needs, understanding international regulatory differences and meeting diverse market authorisation requirements are just some of the challenges you will tackle.

This course offers a clear, practical understanding of global medical device software regulations. Through expert-led sessions, hands-on exercises and real-world case studies, you will gain the insights and skills needed to confidently steer your software through regulatory pathways and bring it successfully to market.

You will also explore best practices for developing and managing regulated software and learn how to implement them effectively without stifling innovation. Discover how to balance flexibility in the early stages of design with the rigorous oversight needed to deliver a final build that is safe, reliable and fully compliant. This nuanced approach is difficult to master without practical experience and informed guidance, and that is exactly what this course provides.

Led by industry experts with extensive hands-on experience, you will leave equipped with the strategies and knowledge to transform your development process and ensure your products meet the highest standards of quality and safety.

Don’t miss this opportunity to strengthen your expertise and drive successful medical device software projects. Register today to secure your place.

This course is part of our range of Medical Devices training courses

Benefits of attending

Examine the borderline between general health and wellness, medical and pharmaceutical software with confidence
Master the criteria that qualify software as a medical device and avoid regulatory missteps
Understand how claim and technology decisions are tied to market authorisation obligations
Identify the pros and cons of splitting your software into platforms and modules
Expand your understanding of EU and US market authorisation processes and obligations for software products
Find out how to define and generate sufficient clinical evidence to bring and keep your software on the market
Get to grips with configurable devices, accessories, systems and parts, and how strategic use can ease your administrative burden
Learn best practices for compliant software development and management while keeping bureaucracy under control
Examine essential techniques to boost product quality and maintain business continuity amid staff changes and evolving IT environments

Who should attend

Product & Strategy
- Business strategists
- Product managers
- Service and sales managers
Regulatory, Legal & Quality
- Regulatory affairs specialists and managers
- Legal professionals
- Compliance officers
- Quality assurance engineers
Engineering, Development & Validation
- Software developers
- System analysts
- Technical writers
- Biomedical engineers
- Clinical validation specialists
- Usability engineers
- Risk management moderators
Project & Clinical Leadership
- Project managers
- Clinical informatics managers
- Clinical research associates
- R&D engineers

This course covers the foundational principles that apply across all software techniques. For those interested in delving deeper into artificial intelligence, machine learning, and generative AI, we offer the Masterclass: Market Authorisation of AI-enabled Medical Devices. Designed as a natural adjunct to this course, the masterclass builds on the concepts introduced here and explores their practical application in AI-driven healthcare solutions.

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This course will cover:

Welcome - introduction to the regulations

Exploratory exercise to discover the borderline between medical device, pharmaceutical, and cosmetic regulation through a case study

Is it a medical device, or not?

Medical device and in vitro diagnostic device definitions, their terminology, and software considerations
Intended purpose and claim specificity
Borderline between medical device software and lifestyle and fitness software

Software qualification

Modules and software with multiple functions
Functional exemptions
Population health and educational software
Search engines, Q&A tools, and chatbots
Resource and workflow management software
Clinical decision software

International comparison

Software as a Medical Device (SaMD) according to the IMDRF
SaMD ≠ Medical Device Software
IMDRF SaMD risk stratification framework and its pitfalls
International differences (US, Canada, South Korea, …)

Case studies on qualification

Considerations for placement on the market

Placing and making available on the market
Subscription models, cloud computing, and software as a service
Pros and cons of the modular approach
Software platforms
Software accessories, systems, components
Legal status of wearables

Case study on regulatory positioning

Case study on wearables

Borderline with medicine legislation

Companion diagnostics, medication management, and adherence apps
Digital therapeutics
Borderline with pharmaceuticals, combination products

Case study on borderline with medicine legislation

EU market authorisation of medical device software

Overview of EU market authorisation process
Engaging with a Notified Body
UDI versus Basic UDI
EUDAMED
Declaration of Conformity
Person Responsible for Regulatory Compliance
Authorized representatives
Economic operators: distributors, importers, and service fulfilment centres
App Stores and Digital Distribution Platforms
Software traceability
Monitoring critical components or platform updates
Software recalls
Unannounced Notified Body Audits
Service updates, upgrades, and other changes

Case study on software distribution

Case study: a great idea for a start-up!

General Safety and Performance Requirements for software

Harmonised standards
Common specifications
GSPR Checklist
Software labelling
Use of language and symbols
IT environment and mobile platforms
Repeatability and reliability of machine learning software
Instructions for use

Practical Construction of a Technical file

Content
Example

US Market authorisation (FDA)

US Code of Federal Regulations and its Implications for Software
510(k) process and de novo process
FDA Guidance’s specific to software
FDA expectations for machine learning software

Case study on US market authorization

Discussion – International go-to-market considerations

Classification of Medical Device Software

Implementing Rules
Classification rules
Software that drives or influences the use of a (hardware) medical device
Classification Rule 11
IMDRF SaMD risk type determination
IMDRF SaMD risk stratification framework and its pitfalls
Classification Rules 13, 15, and 22

Case studies – Classification

Borderline cases

Borderline manual on qualification and classification
Helsinki procedure
Dispute resolution and fair competition

Software Development Models

Symptoms and root causes of poor design control
Waterfall vs Agile, iterative, and spiral development
Principles of good design control
Stage-gated models

Best practices to manage design activities

Project Management
Development Planning
Change Management
Requirements Management
Architecture & Design
Development
Configuration Management
Verification & Validation
Defect Management
Design Reviews

State-of-the-art standards for regulatory compliance

Software Development Standards for regulatory compliance

IEC 62304 Software Lifecycle Management
IEC 82304-1 General Requirements for Product Safety

Managing software suppliers and subcontractors

Managing software suppliers
Outsourcing design activities
Identifying critical suppliers
Managing software platforms and plugins
Using open-source software
Using legacy software

Software usability

Managing the human element of risk
Designing for happiness
Terminology, Roles and Responsibilities
Human factors Engineering
User Experience Design (UXD)
Process

User experience evaluation techniques

Formative evaluation
- User observations
- Walkthroughs
- Heuristic review
- Key-stroke Level Model
Summative evaluation
- Product reaction cards / word association
- Single Ease Question (SEQ)
- System Usability Score (SUS)
- Interface with risk management
Regulatory requirements and standards
- EU MDR/IVDR requirements
- US FDA requirements
- IEC 62366-1, etc.
- Usability guides

Safety Risk Management

Process, terminology, roles
Risk Identification Methodologies
- Checklists
- Grey Box
- Hazard and Operability Analysis (HAZOP)
- Failure Mode and Effects Analysis (FMEA)
- Fault Tree Analysis (FTE)

Risk Control

Risk reduction paradigms
Risk reduction under single fault condition
Inherently safe design
Preventive measures
Corrective measures
Mitigations
Safety notices
Disclosures of residual risk
Risk control strategies

Case study on risk identification

Risk assessment & evaluation

IMDRF terminology
Determining severity and probability of harm
Determining if a risk is acceptable
Benefit-risk assessment
Risk Management Deliverables

Risk management throughout the product lifecycle

Risk management throughout the product lifecycle
Risk management of ESCs, SOUPs, COTS and platforms

Risk perception and communication

Involving external stakeholders in assessing risk
Communication in times of crisis

Core concepts in clinical evaluation of medical software

The regulatory framework of gathering clinical evidence for devices. International differences (EU, US, UK, …)
Clinical evaluation during software lifecycle
Clinical vs performance evaluation
Direct and indirect benefits and risks

Setting the right scope and level of evidence for medical software

Validation of clinical association, technical performance and clinical performance
Role of the standards and scientific literature
Considerations for AI/ML-based devices

The literature review process

Case Studies – clinical evaluation of medical device software

Assessing and documenting clinical evidence: The Clinical Evaluation Report

Clinical and performance studies

When is a clinical investigation needed for medical device software
Selecting appropriate study design
Application of standards
Clinical performance studies
Regulatory and ethical considerations

Post-Market Surveillance and Post-Market Clinical Follow up

Post-market regulatory requirements
The role of Real-World data and Real-World Evidence
Implementing Post-Market Clinical Follow-up for medical device software
Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance

Enrol/reserve

Koen Cobbaert
Philips Healthcare

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the IMDRF on matters related to software and artificial intelligence. He also contributes to various standardisation organizations focusing on software and artificial intelligence.

In the legislative domain, Koen chairs COCIR’s and DITTA’s software focus groups, representing its members at respectively the European Commission MDCG workgroups on Borderline and Classification and New Technologies and at the international level at the International Medical Device Regulators Forum (IMDRF) workgroup on artificial intelligence. Koen is also an advisor in the SaMD workgroup at the Global Harmonization Working Party (GHWP). Currently, Koen is engaged in various proposed EU legislation relating to artificial intelligence and data (AI Act, Machinery Regulation, General Product Safety Directive, Data Act, European Health Data Space…). Aside from various publications through trade associations, Koen also edited the book Software as a Medical Device, published through the Regulatory Affairs Professionals Society (RAPS).

In the standardization domain, Koen is a member of CEN-CENELEC’s Industry Advisory Forum, and he is delegated as a Belgian expert to IEC JTC 1 SC 42 on artificial intelligence, CEN-CENELEC JTC21 on artificial intelligence, ISO TC215 JWG7 on health informatics, and to the IEC SC62A Advisory group on Software, Networks, and Artificial Intelligence (SNAIG).

Koen has a Master of Science in electrical engineering and safety risk management. He has over 15 years of hands-on experience establishing regulatory and market-access strategies for medical device software, performing worldwide regulatory submissions, and moderating risk management and clinical evaluation for software applications for general radiology, oncology, neurology, cardiology, orthopaedics, and clinical pathology. He has worked on software applications for pattern recognition, computer-aided detection, reasoning engines, clinical pathways, and other clinical decision support systems, including mobile apps, embedded software, and software operating in the cloud.

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Zuzanna Kwade
Dedalus Healthcare

Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research and clinical evaluation.

Since 2016, she has been actively involved in Clinical Evaluations according to MEDDEV 2.7.1 (Rev.4) for multiple devices, including high risk hardware devices and medical software. She also represented COCIR in the European Union Task Force on clinical evaluation of software and co-authored MDCG2020-1 guidance on clinical evaluation of MDSW.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

26-30 January 2026

Live online

09:00-17:00 UK (London) (UTC+00)
10:00-18:00 Paris (UTC+01)
04:00-12:00 New York (UTC-05)
Course code 16764

GBP 2,199 2,699
EUR 3,079 3,779
USD 3,539 4,319

Until 22 Dec

5 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

22-26 June 2026

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 16765

GBP 2,199 2,699
EUR 3,079 3,779
USD 3,539 4,319

Until 18 May

5 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.