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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

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

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The content, presenters and format of this course are customised to your requirements.

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Details

Course overview

This intensive four-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

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
  • Borderline 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

  • International comparisons-qualification differences (US, Canada, Brazi,…)
  • Pitfalls with the interpretation of the IMDRF SaMD risk framework
  • Pros and cons of the modular approach
  • software platforms
  • Software accessories, systems components
  • Legal status of wearables

Case studies – qualification

Software classification

  • Implementing rules
  • Software that drives or influences the use of a (hardware) medical 
    device
  • 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
  • Engaging with a Notified Body
  • Controlling software suppliers and subcontractors
  • UDI number
  • EUDAMED
  • 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
  • Unannounced Notified Body audits
  • Service updates, upgrades and other changes

Case study: a great idea!

Safety and performance requirements for software

  • Harmonised standards
  • Common specifications
  • GSPR checklist
  • Software labelling
  • IT environment and mobile platforms
  • Repeatability and reliability of machine learning software
  • Software labeling
  • 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 Guidances specific for software
  • FDA expectations for machine learning 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 reliability of health and wellness apps
  • Evolving policy and reimbursement landscapes for digital health technologies
  • Quality and reliability of health and wellness apps

Controlled design of health software


  • Software development models
    • Symptoms and root causes of poor design control
    • Waterfall vs Agile, iterative and spiral
    • Principles of good design control
    • Stage-gated model
  • Design activities
    • Project management
    • Development planning
    • Change management
    • Requirements management
    • Architecture & design
    • Development
    • Configuration management
    • Verification & validation
    • Defect management
    • Design reviews
  • Software development standards
    • IEC 62304 software life-cycle management
    • IEC 82304-1 general requirements for product safety
  • Outsourcing
    • Management of software suppliers
    • Critical suppliers
    • Software platforms and plugins
    • Use of open source software
    • Legacy software

Software usability

  • Managing the human element of risk
  • Designing for happiness
  • Terminology, roles and responsibilities
  • Use Experience Design (UXD)
  • Process and 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
    • USA FDA requirements
    • IEC 62366-1, etc.
    • Usability guides

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
    • Determining if a risk is acceptable
    • Benefit-risk assessment
    • Deliverables
  • Other risk management aspects
    • Risk management throughout the product life-cycle
    • Risk management of ESCs, SOUPs, COTS and platforms
    • Risk perception and communication

Clinical evaluations

  • Definitions, purpose, deliverables
  • Process and key characteristics
  • Selecting data sources
  • 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

  • What is it and what is included?
  • Who should write it?
  • How to write it
  • Tips & tricks

Development of a literature review protocol

  • Selecting databases and conducting searches
  • Defining search strategy

Case studies – clinical evaluation of medical device software

Clinical investigations and performance studies

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

Post-Market Surveillance and Post-Market Clinical Follow up

  • 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 device software
  • Real-World Evidence
  • Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance to streamline ways of working

Presenter

Koen Cobbaert (More...)

Koen Cobbaert works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys giving training and lectures and thrives on solving complex regulatory challenges.

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, New Technologies and Annex XVI devices 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). 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 delegated as Belgian expert to IEC JTC 1/SC 42 on artificial intelligence, ISO/TC 121/SC 3/JWG 12 on home respiratory equipment, ISO/TC215/JWG7 on health informatics, and to the IEC SC62A advisory group on software, networks and artificial intelligence.

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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Customise & book

This course can be customised to meet your requirements, and delivered to your colleagues at your location or online. For more information, call us on +44 (0)20 7749 4730, email us at inhouse@management-forum.co.uk or contact us below:

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Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Training options

Public course dates

We can deliver and customise this course for any number of attendees, at your location or online. But if you have fewer colleagues, this course is running publically on:

  • 25-28 Apr 2022
  • 4-7 Jul 2022
  • 4-7 Oct 2022

Book now

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Previous customers include...

  • Aidence BV
  • ARES Trading SA
  • Ascensia Diabetes Care Holdings AG
  • Babylon Partners Ltd
  • Blackford Analysis Ltd
  • Cochlear Limited
  • Covidien Deutschland GmbH
  • Debiopharm International SA
  • Foundation for Biomedical Research and Innovation
  • Genomtec SA
  • Groupe Guerbet
  • GSK
  • Guerbet
  • Ipsen
  • Laerdal Medical AS
  • McLaren
  • Medicines and Healthcare Products Regulatory Agency (MHRA)
  • Mirko Fortuna
  • Okko Health
  • RB
  • Technology Partnership Plc
  • Teledyne DALSA
  • Teva Pharmaceuticals Ireland
  • The Institute of Cancer Research
  • TomTom International B.V.
  • Toshiba Medical Visualization Systems
  • UCB
  • University of Cambridge
  • Vision RT Limited
  • Waters-Micromass

I think it has been very useful and interesting, and I believe most people has been involved and participating, which makes it lively and helps you keep in the flow when doing online training.

Luis Mancera Pascual, Executive Director, Clover Bioanalytical Software, Ltd, Nov 20

The seminar was very good, the speakers and slides were very professionals and it covers wide aspects of the learned subjects.

Avital Levertov, Regulatory Affairs Manager, Elcam Medical Ltd, Nov 20

I enjoyed the webinar very much, both presenters were very good and showed their depth of knowledge.

Sabrina Solomon, Safety Scientist, Ipsen, Nov 20

Both very good and enthusiastic speakers. It is very nice that they work with MDSW and have a lot of examples, which makes it more understandable. I liked the course and learned a lot.

Jennie Mettivier Meijer, Project Manager Medical Devices & Quality Systems, BioTop Medical, Nov 19

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

Sandra Beltran Rodil, Associate Director, Regulatory Affairs, Teva UK Ltd, Apr 19

Good

Arun Mahendran, Regulatory Affairs Manager, Vision RT Limited, Apr 19

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, Apr 19

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

Ana Burman, Quality Engineer, Team Consulting, Apr 19

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 , Apr 19

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, Apr 19

A very interesting and informative course. Excellent speakers

Laura Scatizzi, Manager, Fresenius Medical Care Deutschland GmbH, Nov 18

One of the best training courses I have attended.

Ben Sadowyj, Senior Regulatory Assciate - Digital, RB Healthcare UK, Nov 18

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, Nov 18

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., Nov 18

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

Marika Miettinen, Head of Compliance, Tieto Oyj, Nov 18