Medical Device Software: Complying with the MDR & FDA Regulations

An Introduction to Medical Device Software: Regulations & Requirements to include EU & FDA Guidance and Risk Management

28-30 Apr 2020

& 17-19 Nov 2020

GBP 1,849 1,549 *
EUR 2,589 2,169 *
USD 2,884 2,416 *
* When you book before 20 Mar

Book now

Course Overview

This intensive three-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide. The programme will be highly interactive, using real-life examples and state-of-the-art practices identified by Notified Bodies in Europe. There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation. Presentations will also offer practical tips on how to streamline the development process and provide an understanding of the regulatory requirements and how Notified Bodies review technical files.

There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software. Software recalls, the use of apps in medical devices, the implications of the new draft usability standard, and advice on how to validate your system design will also be addressed.


Why you should attend

  • Learn how to qualify and classify software in Europe and the rest of the world
  • Get in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22
  • Understand the implications of the MDR and US Code of Federal Regulations for software
  • Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software
  • Learn how to write 510(k) and technical files
  • Get a practical understanding of quality management, design control and how it applies to agile software development
  • Hear the best practices on cyber security, risk management, usability andvalidation
  • Learn the principles of clinical evaluations for software as a medical device
  • Gain an insight into state-of-the-art standards applicable to software

Who should attend?

  • Senior management and project leaders
  • Software product managers, researchers, developers and clinical experts
  • Software development process managers
  • IT managers and integrators
  • Internal and external auditors and/or consultants
  • Regulatory affairs professionals
  • Quality system and quality assurance personnel
  • Technical and medical writers
  • GUI designers

Programme day one

Introduction to the regulations

Software qualification – is it a medical device or not?

  • Medical device definitions
  • In-vitro diagnostic software
  • Multi-functionality software
  • Cloud computing and software as a service
  • Intended purpose
  • Excluded functionality
  • Borderline with lifestyle and fitness software
  • Bordeline with pharmaceuticals, combination products
  • Companion diagnostics, medication management and adherence apps
  • Population health and educational software
  • Resource and workflow management vs clinical decision support software
  • Clinical decision software
Considerations for placement on the market
  • Internationa comparisons-qualification differences (US, Canada, Brazi,…)
  • Pitfalls with the interpretation of the IMDRF SaMD risk framework
  • Pos and cons of the modular approach
  • software platforms
  • Software accessories, systems components

Case studies – qualification

Software classification
  • Implementing rules
  • Software that drives or influences the use of a (hardware) medical
  • Classification rules, including classification rule 11
  • IMDRF SaMD risk type determination
Case studies – classification

MDR in a nutshell with software considerations

  • Go to market process
  • Enagaging with a Notified Body
  • Controlling software suppliers and subcontractors
  • UDI number
  • Declaration of Conformity
  • Person responsible for regulatory compliance
  • Software traceability
  • Distributors, importers, authorised representatives and their liability
  • App stores and digital distribution platforms
  • Software recalls
  • Unannouced Notified Body audits
  • Service updates, upgrades and other changes

Programme day two

Safety and performance requirements for software
  • Harmonised standards
  • Common specifications
  • GSPR checklist
  • Software labelling
  • Instructions for use
Practical construction of a technical file
  • Content
  • Example
Placing medical device software on the US market
  • US Code of Federal Regulations and its implications for software
  • 510(k) process
  • FDA guidance for software
Practical construction of a 510(k) International go-to-market considerations
  • Challenges faced for app developers to have their app taken up in care pathways
  • Quality and reliablility of health and wellness apps
  • Evovling policy and reimbursement landscapes for digital health technologies
  • Quality and reliability of health and wellness apps
Controlled design of heath software
  • Software development models
    • Symptoms and root causes of poor design control
    • Waterfall vs Agile, iteratvie and spiral
    • Principles of good desing control
    • Stage-gated model
  • Design activities
    • Project management
    • Development planning
    • Change management
    • Requirements management
    • Architecture & design
    • Development
    • Configuration management
    • Verification & validation
    • Defect management
    • Design reveiws
  • Software development standards
    • IEC 62304 software lifecycle management
    • IEC 82304-1 general requirements for product safety
  • Outsourcing
    • Management of software suppliers
    • Critical suppliers
    • Use of open source software
    • Leagacy software
Software usability
  • Managing the human elemnt of risk
  • Designing for happiness
  • Terminology, roles and responsibilities
  • Use Experience Design (USD)
  • Process and techniques
  • Formative evaluation
    • User obeservations
    • Walkthroughs
    • Heruistic review
    • Key-stroke level model
  • Summative evaluation
    • Product reaction cards / word association
    • Single Ease Question (SEQ)
    • System Usability Score (SUS)
    • Interfacw with risk management
  • Regulatory requiremetns and standards
    • EU MDR/IVDR requirements
    • USA FDA requirements
    • IEC 62366-1, etc.
    • Usability guides

Programme day three

Clinical evaluations
  • Definitions, purpose, deliverables
  • Process and key characteristics
  • Methodology
  • Selecting data sources
  • The literature review process
  • Defining a scope and a sufficient level of clinical evidence for medical device software
  • Role of validation and usability
  • Considerations for artificial intelligence and continuous learning software

Practical construction of a clinical evaluation plan and report

Development of a literature review protocol

Case studies – clinical evaluation of medical device software

Clinical investigations

  • General principles of clinical investigations
  • When is a clinical investigation needed for medical device software
  • Selecting appropriate study design
  • Application of standars
  • Clinical performance studies
  • Generating evidence of effectiveness
  • Challenges of mHealth trials
  • Reporting
  • Regulatory and ethical considerations

Safety risk management – ISO 14971

  • Process, terminology, roles
  • Risk identification methodologies
    • Checklists
    • Grey box
    • Hazard and Operability Analysis (HAZOP)
    • Failure Modes and Effects Anaylsis (FMEA)
    • Fault Tree Analysis (FTE)
  • Risk Control
    • Inherently safe design
    • Preventive measures
    • Corrective measures
    • Mitigations
    • Safety notices
    • Disclosures of residual risk
    • Risk control strategies
  • Risk assessment and evaluation
    • IMDRF terminology
    • Determining severity and probability of harm
    • Deteriniming if a risk is acceptable
    • Benefit-risk assessment
    • Deliverables
  • Manufacturer accountability
    • Risk management throughout the product lifecycle
    • Normal,abnormal and misuse
    • ESCs, SOUPs and COTs
    • Platform changes and failures

Case studies – risk management

Post-Market Surveillance

  • Post-market regulatory requirements
  • Components of an effective PMS
  • Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting
  • Implementation of Post Market Clinical Follow-up for medical devive software
  • Real-world evidence
  • Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working


Koen Cobbaert

Koen Cobbaert is Quality and Regulatory Manager at Philips Healthcare. He represents COCIR in numerous work groups at European level. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electro-medical industries. In 2009 COCIR created its software task force, which Koen has been chairing ever since. He put on paper the first draft of the qualification decision tree, which was later successfully adopted by the Member States in “MEDDEV 2.1/6 on the qualification and classification of standalone software”. Under Koen’s leadership COCIR’s software task force has contributed to the 1st and 2nd edition of this MEDDEV and has proposed the IMDRF work item on software as a medical device, which ultimately lead to IMDRF guidance on the qualification, risk stratification and clinical evaluation of software as a medical device. Currently Koen’s work focuses on drafting the European guidance for classification of medical device software, which is expected to clarify among others the use of classification rule 10 and 11 under the Medical Device Regulation (MDR).
Koen wrote several COCIR papers on a variety of software-related topics under the MDR: qualification of and responsibilities for rules engines, programming and runtime environments and libraries for dataflow programming and machine learning, economic operator requirements for app stores and digital marketplaces, significant changes of software, UDI numbers, etc.Via COCIR’s standards focus group he contributed to the development of IEC 82304 on safety requirements for health software and IEC 62304 on software lifecycle processes. Koen co-authored the FAQ on IEC 62304, which has been translated in several languages. Via COCIR’s North American sister organisation MITA he also contributed to several FDA guidance papers, including the guidance papers on patient and clinical decision support systems and on computer-assisted detection devices applied to radiology images and radiology device data.
Koen has over 15 years of hands-on experience in establishing regulatory strategies, writing technical files and 510(k)s, performing worldwide regulatory submissions and moderating risk management and clinical evaluation discussions for software applications for general radiology, oncology, neurology, cardiology and orthopaedics, computer algorithms for pattern recognition, computer aided detection, reasoning engines, decision support, clinical pathways, general systems such as HIS, LIS, IVD, PACS, EPR and mobile apps. He has a Master in Risk Management and Electrical Engineering.

Zuzanna Kwade

Zuzanna Kwade is Medical Affairs Manager, Agfa Healthcare. Zusanna holds a PhD in Biochemistry and has more than ten years of experience in clinical and medical research. She is the co-author of several white papers on regulatory aspects of clinical research.

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 represents COCIR in the European Union Task Force on clinical evaluation of software.

Book now

28-30 Apr 2020
28-30 Apr 2020 Holiday Inn London - Kensington Forum, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
GBP 1,549.00
EUR 2,169.00
USD 2,416.00
Until 20 Mar*
Enrol now
17-19 Nov 2020
17-19 Nov 2020 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

* Note the early booking discount cannot be combined with any other offers or promotional code

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Previous customers include...

  • Aidence BV
  • BioTop Medical
  • CGI IT UK Limited
  • Chiesi Farmaceutici S.p.a.
  • Coloplast A/S
  • DCA Design International
  • Debiopharm International SA
  • Emis Ltd
  • Hoffman LaRoche
  • Hospira, a Pfizer Company
  • IBA
  • MED-EL Medical Electronics
  • MedTech Europe
  • Mundipharma Research Ltd
  • Nemaura Pharma
  • Oticon A/S
  • PA Consulting
  • PA Consulting Group
  • Roche
  • Saudi Food and Drug Authority
  • Team Consulting
  • Teledyne DALSA
  • Teva UK Limited
  • Teva UK Ltd
  • The Institute of Cancer Research
  • Thermo Fisher Scientific Baltics
  • UCB
  • Vision RT Limited
  • Wellspect Healthcare
  • Yonsei University

Both speakers were really good and brought the needed perspective to the discussion.

Sandra Beltran Rodil, Senior Manager Regulatory Affairs, Teva UK Ltd

Good course, very interesting and complete overview with speakers that bring the insights of both an ex-auditor and an industry representative.

Antoine Nguyen, Associate Regulatory Program Manager , Roche

A good intensive course - I would recommend for my colleagues especially who need a general understanding of MDR impact on medical SW.

Camilla Inesa Cernajute, Regulatory Affairs Officer, Oticon A/S

The course is well thought and based on the expert's experiences.

Ana Burman, Quality Engineer, Team Consulting


Arun Mahendran, Regulatory Affairs Manager, Vision RT Limited

A very worthwhile introduction to the regulatory requirements of medical device software for anyone new to this device type. The course covered a broad range of relevant subjects and was delivered by speakers who were clearly highly experienced but also passionate about the subject matter. I would definitely recommend!

Suzanne Morgan, Group Head of Regulatory Affairs, The BBI Group

This is one of the best training organised by Management Forum in term of the quality of the content and presenters. I am equipped to do my job!

Cadence Tan, Senior Regulatory Affairs Manager, GSK Consumer Healthcare

Engaging delivery of the subject by speakers who clearly had extensive knowledge and experience of medical device software in a regulatory environment.

Stephen Matthews, Validation Consultant, Smart Process Solutions Ltd.

A very interesting and informative course. Excellent speakers

Laura Scatizzi, Manager, Fresenius Medical Care Deutschland GmbH

Big thank you to Koen! He shared the latest information of the risk classification guidance.

Marika Miettinen, Head of Compliance, Tieto Oyj

One of the best training courses I have attended.

Ben Sadowyj, Senior Regulatory Assciate - Digital, RB Healthcare UK

Koen brought a lot of practical industry experience which was extremely useful.

Leon Doorn, Sr. QA/RA Manager, Aidence B.V.

A well structured, well presented programme

Peter Ogrodnik, Professor of Biomedical Engineering, Keele University

The speakers were knowlegdable and interesting.

Cecile Boyer, Senior Quality Project Manager, Novartis Pharma AG

Good course. A lot of information in detail.

Jose Fernandez, Certification Manager, McLaren

Excellent content - good choice of speakers

Malgorzata Wilinska, Research Associate, University of Cambridge

It was great that both speakers had an understanding of what devices IBA makes and they tried to give suitable answers for our case

Inez Wathion, Verification & Validation Officer, Ion Beam Applications SA

Very good presentation

Massimo Panonzini, Inpeco SA

Very good

Robert Gay, Senior Regulatory Affairs Manager - External Products and Software, Cochlear Limited

The presentations in the folders did not follow the order that was presented by the speakers. Always best to check beforehand with the speakers the order of information as ideally it should match of presentation. This meant we were all looking for the slides whilst the speakers had started, meaning we often missed some important points.

Priti Darjee, Associate Director Regulatory Affairs, UK, Teva UK Ltd

Very good, I would recommend this course for beginners and advanced levels

Arnaud Biermann, Senior Manager Regulatory Affairs, Anteis SA