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 worldGet in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22Understand the implications of the MDR and US Code of Federal Regulations for softwareGain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning softwareLearn how to write 510(k) and technical filesGet a practical understanding of quality management, design control and how it applies to agile software developmentHear the best practices on cyber security, risk management, usability and validationLearn the principles of clinical evaluations for software as a medical deviceGain an insight into state-of-the-art standards applicable to software

Certifications

CPD: 24 hours for your recordsCertificate of completion

Who Should Attend:

Senior management and project leadersSoftware product managers, researchers, developers and clinical expertsSoftware development process managersIT managers and integratorsInternal and external auditors and/or consultantsRegulatory affairs professionalsQuality system and quality assurance personnelTechnical and medical writersGUI designers

Agenda:

Day 1

Introduction to the regulations

Software qualification – is it a medical device or not?

Medical device definitionsIn-vitro diagnostic softwareMulti-functionality softwareCloud computing and software as a serviceIntended purposeExcluded functionalityBorderline with lifestyle and fitness softwareBorderline with pharmaceuticals, combination productsCompanion diagnostics, medication management and adherence appsPopulation health and educational softwareResource and workflow management vs clinical decision support softwareClinical decision software

Considerations for placement on the market

International comparisons-qualification differences (US, Canada, Brazi,.)Pitfalls with the interpretation of the IMDRF SaMD risk frameworkPros and cons of the modular approachsoftware platformsSoftware accessories, systems componentsLegal status of wearables

Case studies – qualification

Day 2

Software classification

Implementing rulesSoftware that drives or influences the use of a (hardware) medicaldeviceClassification rules, including classification rule 11IMDRF SaMD risk type determination

Case studies – classification

MDR in a nutshell with software considerations

Go to market processEngaging with a Notified BodyControlling software suppliers and subcontractorsUDI numberEUDAMEDDeclaration of ConformityPerson responsible for regulatory complianceSoftware traceabilityDistributors, importers, authorised representatives and their liabilityApp stores and digital distribution platformsSoftware recallsUnannounced Notified Body auditsService updates, upgrades and other changes

Case study: a great idea!

Safety and performance requirements for software

Harmonised standardsCommon specificationsGSPR checklistSoftware labellingIT environment and mobile platformsRepeatability and reliability of machine learning softwareSoftware labelingInstructions for use

Practical construction of a technical file

ContentExample

Placing medical device software on the US market

US Code of Federal Regulations and its’ implications for software510(k) processFDA Guidances specific for softwareFDA 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 pathwaysQuality and reliability of health and wellness appsEvolving policy and reimbursement landscapes for digital health technologiesQuality and reliability of health and wellness apps

Day 3

Controlled design of health software

Software development modelsSymptoms and root causes of poor design controlWaterfall vs Agile, iterative and spiralPrinciples of good design controlStage-gated modelDesign activitiesProject managementDevelopment planningChange managementRequirements managementArchitecture & designDevelopmentConfiguration managementVerification & validationDefect managementDesign reviewsSoftware development standardsIEC 62304 software life-cycle managementIEC 82304-1 general requirements for product safetyOutsourcingManagement of software suppliersCritical suppliersSoftware platforms and pluginsUse of open source softwareLegacy software

Software usability

Managing the human element of riskDesigning for happinessTerminology, roles and responsibilitiesUse Experience Design (UXD)Process and techniquesFormative evaluationUser observationsWalkthroughsHeuristic reviewKey-stroke level modelSummative evaluationProduct reaction cards / word associationSingle Ease Question (SEQ)System Usability Score (SUS)Interface with risk managementRegulatory requirements and standardsEU MDR/IVDR requirementsUSA FDA requirementsIEC 62366-1, etc.Usability guides

Safety risk management – ISO 14971

Process, terminology, rolesRisk Identification MethodologiesChecklistsGrey boxHazard and Operability Analysis (HAZOP)Failure Modes and Effects Anaylsis (FMEA)Fault Tree Analysis (FTE)Risk ControlInherently safe designPreventive measuresCorrective measuresMitigationsSafety noticesDisclosures of residual riskRisk control strategiesRisk assessment and evaluationIMDRF terminologyDetermining severity and probability of harmDetermining if a risk is acceptableBenefit-risk assessmentDeliverablesOther risk management aspectsRisk management throughout the product life-cycleRisk management of ESCs, SOUPs, COTS and platformsRisk perception and communication

Day 4

Clinical evaluations

Definitions, purpose, deliverablesProcess and key characteristicsSelecting data sourcesDefining a scope and a sufficient level of clinical evidence for medical device softwareRole of validation and usabilityConsiderations for artificial intelligence and continuous learning software

Development of a literature review protocol

Selecting databases and conducting searchesDefining search strategy

Case studies – clinical evaluation of medical device software

Clinical investigations and performance studies

General principles of clinical investigationsWhen is a clinical investigation needed for medical device softwareSelecting appropriate study designApplication of standardsClinical performance studiesGenerating evidence of effectivenessChallenges of health trialsReportingRegulatory and ethical considerations

Post-Market Surveillance and Post-Market Clinical Follow up

Post-market regulatory requirementsComponents of an effective PMSProcess interface with CAPA, NC, vigilance, service, periodic safety updates, trend reportingImplementation of Post Market Clinical Follow-up for medical device softwareReal-World EvidenceSuccessfully 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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