DUBLIN--(BUSINESS WIRE)--The 'Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations' conference has been added to ResearchAndMarkets.com's offering.

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This intensive four-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide.

这门为期四天的强化课程全面评估了适用于全球医疗器械软件的法规和要求。

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.

该计划将高度互动，使用现实生活中的例子和欧洲通知机构确定的最新实践。将深入介绍如何为医疗器械软件产品准备符合要求的技术文件文档，以及对软件规范、风险管理、体系结构、可用性和最终设计文档的审查。

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..

演示还将提供有关如何简化开发过程的实用技巧，并提供对法规要求的理解，以及通知机构如何审查技术文件。。

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..

会议将讨论风险管理和可用性的实际意义，并分析FDA指南和MDR指南在医疗器械软件方面的差异。软件召回、应用程序在医疗设备中的使用、新的可用性标准草案的含义以及如何验证系统设计的建议也将得到解决。。

This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.

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Why you should attend

你为什么要参加

Learn how to qualify and classify software in Europe and the rest of the world

了解如何对欧洲和世界其他地区的软件进行鉴定和分类

Get in-depth understanding of the interpretations of MDR Classification Rules 10, 11, 12, 13, 15 and 22

深入了解MDR分类规则10、11、12、13、15和22的解释

Understand the implications of the MDR and US Code of Federal Regulations for software

了解MDR和美国联邦法规对软件的影响

Gain regulatory guidance on mobile apps, software as a service, cloud computing, artificial intelligence and continuous learning software

获得有关移动应用程序、软件即服务、云计算、人工智能和持续学习软件的监管指导

Learn how to write 510(k) and technical files

了解如何编写510（k）和技术文件

Get a practical understanding of quality management, design control and how it applies to agile software development

实际了解质量管理、设计控制以及它如何应用于敏捷软件开发

Hear the best practices on cyber security, risk management, usability and validation

听取有关网络安全、风险管理、可用性和验证的最佳实践

Learn the principles of clinical evaluations for software as a medical device

学习软件作为医疗设备的临床评估原则

Gain an insight into state-of-the-art standards applicable to software

深入了解适用于软件的最新标准

Certifications

所获证书

CPD: 24 hours for your records

CPD：24小时记录

Certificate of completion

竣工证书

Who Should Attend:

参加人员：

Senior management and project leaders

高级管理人员和项目负责人

Software product managers, researchers, developers and clinical experts

软件产品经理、研究人员、开发人员和临床专家

Software development process managers

软件开发过程经理

IT managers and integrators

IT经理和集成商

Internal and external auditors and/or consultants

内部和外部审计师和/或顾问

Regulatory affairs professionals

监管事务专业人员

Quality system and quality assurance personnel

质量体系和质量保证人员

Technical and medical writers

技术和医学作家

GUI designers

GUI设计器

Agenda:

议程：

Day 1

第1天

Introduction to the regulations

条例简介

Software qualification - is it a medical device or not?

软件鉴定-它是否是医疗设备？

Medical device definitions

医疗器械定义

In-vitro diagnostic software

体外诊断软件

Multi-functionality software

多功能软件

Cloud computing and software as a service

云计算和软件即服务

Intended purpose

预期用途

Excluded functionality

排除的功能

Borderline with lifestyle and fitness software

生活方式和健身软件的边缘

Borderline with pharmaceuticals, combination products

与药品、组合产品接壤

Companion diagnostics, medication management and adherence apps

配套诊断、药物管理和依从性应用程序

Population health and educational software

人口健康与教育软件

Resource and workflow management vs clinical decision support software

资源和工作流管理与临床决策支持软件

Clinical decision software

临床决策软件

Considerations for placement on the market

关于上市的考虑

International comparisons-qualification differences (US, Canada, Brazil)

国际比较资格差异（美国、加拿大、巴西）

Pitfalls with the interpretation of the IMDRF SaMD risk framework

IMDRF SaMD风险框架解释中的陷阱

Pros and cons of the modular approach software platforms

模块化方法软件平台的优缺点

Software accessories, systems components

软件附件、系统组件

Legal status of wearables

可穿戴设备的法律地位

Case studies - qualification

案例研究-资格

Day 2

第2天

Software classification

Implementing rules

实施规则

Software that drives or influences the use of a (hardware) medical device

驱动或影响（硬件）医疗设备使用的软件

Classification rules, including classification rule 11

分类规则，包括分类规则11

IMDRF SaMD risk type determination

IMDRF SaMD风险类型确定

Case studies - classification

案例研究-分类

MDR in a nutshell with software considerations

简而言之，MDR需要考虑软件因素

Go to market process

上市流程

Engaging with a Notified Body

与公告机构接洽

Controlling software suppliers and subcontractors

控制软件供应商和分包商

UDI number

EUDAMED

尤达梅德

Declaration of Conformity

符合性声明

Person responsible for regulatory compliance

法规遵从性负责人

Software traceability

软件可追溯性

Distributors, importers, authorised representatives and their liability

分销商、进口商、授权代表及其责任

App stores and digital distribution platforms

应用商店和数字分发平台

Software recalls

软件召回

Unannounced Notified Body audits

未经通知的审计机构

Service updates, upgrades and other changes

服务更新、升级和其他更改

Case study: a great idea!

案例研究：一个好主意！

Safety and performance requirements for software

软件的安全和性能要求

Harmonised standards

调和标准

Common specifications

通用规范

GSPR checklist

GSPR检查表

Software labelling

软件标签

IT environment and mobile platforms

IT环境和移动平台

Repeatability and reliability of machine learning software

机器学习软件的可重复性和可靠性

Software labeling

软件标签

Instructions for use

使用说明

Practical construction of a technical file

技术档案的实际建设

Content

内容

Example

示例

Placing medical device software on the US market

将医疗器械软件投放美国市场

US Code of Federal Regulations and its' implications for software

美国联邦法规及其对软件的影响

510(k) process

510（k）工艺

FDA Guidances specific for software

FDA软件专用指南

FDA expectations for machine learning software

FDA对机器学习软件的期望

Practical construction of a 510(k)

510（k）的实际构造

International go-to-market considerations

Challenges faced for app developers to have their app taken up in care pathways

应用程序开发人员将其应用程序纳入护理路径所面临的挑战

Quality and reliability of health and wellness apps

健康和健康应用程序的质量和可靠性

Evolving policy and reimbursement landscapes for digital health technologies

数字健康技术政策和报销格局的演变

Quality and reliability of health and wellness apps

健康和健康应用程序的质量和可靠性

Day 3

第3天

Controlled design of health software

健康软件的受控设计

Software development models

软件开发模型

Symptoms and root causes of poor design control

设计控制不佳的症状和根本原因

Waterfall vs Agile, iterative and spiral

瀑布vs敏捷、迭代和螺旋

Principles of good design control

良好设计控制原则

Stage-gated model

阶段门控模型

Design activities

设计活动

Project management

项目管理

Development planning

发展规划

Change management

变更管理

Requirements management

需求管理

Architecture & design

建筑与设计

Development

发展

Configuration management

配置管理

Verification & validation

验证和确认

Defect management

缺陷管理

Design reviews

设计审查

Software development standards

软件开发标准

IEC 62304 software life-cycle management

IEC 62304软件生命周期管理

IEC 82304-1 general requirements for product safety

IEC 82304-1产品安全的一般要求

Outsourcing

外包

Management of software suppliers

软件供应商管理

Critical suppliers

关键供应商

Software platforms and plugins

软件平台和插件

Use of open source software

使用开源软件

Legacy software

遗留软件

Software usability

软件可用性

Managing the human element of risk

管理风险的人为因素

Designing for happiness

为幸福而设计

Terminology, roles and responsibilities

术语、角色和责任

Use Experience Design (UXD)

使用体验设计（UXD）

Process and techniques

工艺和技术

Formative evaluation

形成性评价

User observations

用户观察

Walkthroughs

演练

Heuristic review

启发式审查

Key-stroke level model

关键行程级别模型

Summative evaluation

总结性评价

Product reaction cards / word association

产品反应卡/单词关联

Single Ease Question (SEQ)

单一缓解问题（SEQ）

System Usability Score (SUS)

系统可用性评分（SUS）

Interface with risk management

与风险管理的接口

Regulatory requirements and standards

监管要求和标准

EU MDR/IVDR requirements

欧盟MDR/IVDR要求

USA FDA requirements

美国FDA要求

IEC 62366-1, etc.

IEC 62366-1等。

Usability guides

Safety risk management - ISO 14971

Process, terminology, roles

流程、术语、角色

Risk Identification Methodologies

风险识别方法

Checklists

检查表

Grey box

灰色方框

Hazard and Operability Analysis (HAZOP)

危害和可操作性分析（HAZOP）

Failure Modes and Effects Anaylsis (FMEA)

故障模式和影响分析（FMEA）

Fault Tree Analysis (FTE)

故障树分析（FTE）

Risk Control

风险控制

Inherently safe design

本质安全设计

Preventive measures

预防措施

Corrective measures

纠正措施

Mitigations

缓解措施

Safety notices

安全注意事项

Disclosures of residual risk

剩余风险披露

Risk control strategies

风险控制策略

Risk assessment and evaluation

风险评估和评估

IMDRF terminology

IMDRF术语

Determining severity and probability of harm

确定危害的严重程度和可能性

Determining if a risk is acceptable

Benefit-risk assessment

Deliverables

Other risk management aspects

其他风险管理方面

Risk management throughout the product life-cycle

整个产品生命周期的风险管理

Risk management of ESCs, SOUPs, COTS and platforms

ESC、汤、COTS和平台的风险管理

Risk perception and communication

风险感知和沟通

Day 4

第4天

Clinical evaluations

Definitions, purpose, deliverables

定义、目的、可交付成果

Process and key characteristics

Selecting data sources

选择数据源

Defining a scope and a sufficient level of clinical evidence for medical device software

定义医疗器械软件的范围和足够水平的临床证据

Role of validation and usability

验证和可用性的作用

Considerations for artificial intelligence and continuous learning software

关于人工智能和持续学习软件的思考

Development of a literature review protocol

制定文献综述方案

Selecting databases and conducting searches

选择数据库并进行搜索

Defining search strategy

定义搜索策略

Case studies - clinical evaluation of medical device software

案例研究-医疗器械软件的临床评估

Clinical investigations and performance studies

临床调查和性能研究

General principles of clinical investigations

临床研究的一般原则

When is a clinical investigation needed for medical device software

医疗器械软件何时需要临床调查

Selecting appropriate study design

选择合适的研究设计

Application of standards

标准的应用

Clinical performance studies

临床表现研究

Generating evidence of effectiveness

产生有效性证据

Challenges of health trials

Reporting

Regulatory and ethical considerations

监管和道德考虑

Post-Market Surveillance and Post-Market Clinical Follow up

上市后监测和上市后临床随访

Post-market regulatory requirements

上市后监管要求

Components of an effective PMS

有效PMS的组成部分

Process interface with CAPA, NC, vigilance, service, periodic safety updates, trend reporting

与CAPA、NC、警戒、服务、定期安全更新、趋势报告的流程接口

Implementation of Post Market Clinical Follow-up for medical device software

医疗器械软件上市后临床随访的实施

Real-World Evidence

真实世界的证据

Successfully bringing together Risk Management, Clinical Evaluation and Post Market Surveillance to streamline ways of working

成功地将风险管理、临床评估和上市后监测结合在一起，以简化工作方式

Speakers:

发言人：

Koen Cobbaert

柯恩·科巴特

Agfa HealthCare

爱克发医疗保健

QARA Manager

QARA经理

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.

科恩·科伯特是COCIR软件工作组的主席。他是独立软件MEDDEV 2.1/6第一版和62304:2006常见问题解答的作者之一。

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.

在日常工作中，他在Agfa Healthcare担任监管事务和质量保证专业人员，负责开发用于普通放射学、核医学、心脏病学和骨科领域的软件应用程序。

He has a masters in electrical engineering and risk management and manages Agfa's product safety risk management process.

他拥有电气工程和风险管理硕士学位，并管理Agfa的产品安全风险管理流程。

For more information about this conference visit https://www.researchandmarkets.com/r/bxauic

有关本次会议的更多信息，请访问https://www.researchandmarkets.com/r/bxauic

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