Fully understand the regulatory requirements under the MDR to ensure compliance throughout the product life cycle
Course Overview
在欧洲，归类为医疗设备的产品受严格的监管要求，以确保产品的安全性和性能。为了保持患者安全，欧盟推出了医疗器械调节（MDR）转换和现代化较旧指令。无论您是新的监管事务，MDR还是从更广泛的医疗器械行业的其他领域分支，这一基本级课程将详细介绍整个产品生命周期的欧盟监管要求。
补充with practical exercises and open discussions, you will gain a comprehensive overview of the essential European regulatory requirements to consider as you prepare for MDR implementation, including the European regulatory landscape, device classification and conformity assessments, documentation and labelling requirements, post-market considerations, risk management and clinical evaluations.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.
Over a week students will learn through:
- 现场互动一口体积会话
- Direct interaction with the trainer during live sessions
- Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
- Revisiting recorded sessions with unlimited access for 30 days
- 与在场会议期间和在线论坛的对等人互动
时间和日期可能会进行更改 - 将提供登录详细信息的最终确认。代表将在课程开始日期的一周内收到登录说明。如果您有任何疑问，请联系lifesciences-training@informa.com..
你会学到什么？
医疗器械规则（MDR）
医疗器械规则（MDR）
了解新医疗设备的规定以及它将如何影响您
What will change?
What will change?
彻底了解医疗器械的规定如何在欧盟应用的医疗设备调节下改变
Classification
Classification
Learn how to classify medical devices
Labelling
Labelling
Determine the correct information required for medical device labelling
关键人物;主力;重要一员
关键人物;主力;重要一员
Understand the role of the Notified Body and Competent Authority
风险管理
风险管理
Examine the risk management process for medical devices
How the MDR affects software
How the MDR affects software
讨论软件和方法解决这些问题的监管挑战
Who is this course for?
- 监管事务专业人士寻求提高监管环境中的技能。
- Those moving into Regulatory Affairs from other areas within a medical device company (Clinical Trial Evaluations, Marketing and others).
- Anyone wishing to update their knowledge on EU regulatory affairs.
CPD认证
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
我们的现场上在线学院的代表说......
94%
97％
97％
Routledge书籍25％的折扣
As a student on the course, you will receive a 25% discount on any Routledge books or eBooks. To view the full product range visit the Routledge websitewww.routledge.com..
Examples of books and eBooks within medical devices include:
- 医疗设备质量保证和监管合规性
- 医疗器械和设备：原则和实践
- Design Controls for the Medical Device Industry, Third Edition
- Usability Testing of Medical Devices
- 和更多
