Medical Device Software Course: Complying with the EU MDR, EU IVDR & FDA Regulations - 4 Day Online Event, July 22-25, 2024
DUBLIN, March 11, 2024 /PRNewswire/ -- The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering.
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.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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 and validation
Learn the principles of clinical evaluations for software as a medical device
Gain an insight into state-of-the-art standards applicable to software
Certifications
CPD: 24 hours for your records
Certificate of completion
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
Agenda:
Day 1
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
Day 2
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
Day 3
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
Day 4
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
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
Speakers:
Koen Cobbaert
Agfa HealthCare
QARA Manager
Koen Cobbaert is chair of COCIR's software task force. He is one of the authors of the first edition of MEDDEV 2.1/6 on standalone software and the FAQ on 62304:2006.
In his day to day job he works for Agfa Healthcare as regulatory affairs and quality assurance professional in the development of software applications for use in the fields of general radiology, nuclear medicine, cardiology and orthopaedics.
He has a masters in electrical engineering and risk management and manages Agfa's product safety risk management process.
For more information about this conference visit https://www.researchandmarkets.com/r/9fsw6o
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