获得所涉及的过程的实际概述，将医疗设备带到由专业学院领导的市场
Course Overview
Medical Device School provides an ideal opportunity to gain a comprehensive overview of medical devices in a relaxed learning atmosphere. Get to grips with the entire medical device lifecycle, through the research and development stages to latest updates in regulatory requirements and post-market considerations. The school will provide an in-depth focus on the changes within the global regulatory landscape, including discussions on Brexit and the new Medical Device Regulation.
The three-day event is composed of a mixture of lecture-style presentations and practical sessions where all can benefit from the speakers’ wealth of knowledge. Gain valuable information and share experiences with some of the most highly respected professionals in the field and perfect your understanding of the EU medical device landscape.
Our School includes 5 interactive learning sessions on Classification, Risk Management, Biocompatibility, Vigilance and Human Factors Engineering.
你会学到什么？
导航新的医疗设备规则（MDR）
导航新的医疗设备规则（MDR）
了解并探索新MDR周围立法的最新变化
监管的差异
监管的差异
Explore the differences between the IVDD and IVDR
Global regulatory landscape
Global regulatory landscape
Gain a comprehensive understanding of the global regulatory landscape alongside Brexit and its implications
Device regulation essentials
Device regulation essentials
Learn the fundamentals of device regulations such as classification and conformity assessment
Biological evaluations
Biological evaluations
Discover how to conduct a biological evaluation
Risk management
Risk management
Examine the importance of having a robust risk management plan
Clinical investigations for devices
Clinical investigations for devices
深入了解设备的临床调查
Implementing a quality management system
Implementing a quality management system
Understand the need for having a quality management system in place
Reimbursement strategies
Reimbursement strategies
Discover optimal reimbursement strategies to get your device paid by healthcare providers such as the NHS
Post-market surveillance
Post-market surveillance
Gain insight into post-market surveillance and vigilance to ensure your devices continue to be safe on the market
Who is this course for?
The school is designed for all those who want to improve and broaden their knowledge of the medical devices industry, whether you are an existing employee, graduate, new to an area/department or somebody who would benefit for future career development.
CPD Certified
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.
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
- And more
