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Medical Device Software: Complying with the EU (European Union) MDR (Medical Device 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.
Details
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.
PLEASE NOTE DAY 3 CAN BE BOOKED AS A ONE DAY COURSE, PLEASE CONTACT US IF YOU WOULD LIKE TO TAKE THIS OPTION ON: info@management-forum.co.uk
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
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
Safety and performance requirements for software
- 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)
- 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
International go-to-market considerations
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
- 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 (USD)
- 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
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 standards
- Clinical performance studies
- Generating evidence of effectiveness
- Challenges of health 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
- Determining if a risk is acceptable
- Benefit-risk assessment
- Deliverables
- Manufacturer accountability
- Risk management throughout the product life-cycle
- 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 device software
- Real-world evidence
- Successfully bringing together risk management, clinical evaluation and PMS to streamline ways of working
Presenters
Koen Cobbaert (More...)
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 (More...)
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.
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