Gain an in-depth understanding of how the new Medical Device Regulation will apply to clinical investigations of medical devices
Course Overview
To improve patient safety the Medical Device Regulation (MDR) puts a greater emphasis on clinical data to provide evidence of safety, especially for riskier products. As a result more clinical data is required by manufacturers, which in turn means more clinical investigations must be undertaken to generate the data.
But what is required to perform a trial?
What requirements must you follow?
How should the study be designed?
This 5 module course will examine the requirements and design protocols of clinical investigations for new devices with case study examples. You will learn also about post-market clinical follow-up studies for existing products and will look at the impact of the new Regulation.
Online Academies
MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.
Over 4 weeks students will learn through:
- 5 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- 回顾内容与无限的访问l the materials for 3 months
- Participating in the discussion forum to interact with other students
- Interacting with the trainer through the forum during the course
- Additional content such as materials and white papers available to download
Delegates will receive login instructions within a week of the course start date. If you have any questions please contactlifesciences-training@informa.com.
What will you learn?
Clinical Investigation planning
Clinical Investigation planning
Understand protocol and regulation around Clinical Investigation planning and conduct
Post-market clinical studies
Post-market clinical studies
Assess post-market clinical studies for existing products and examine how requirements will change with the new Regulation
Study design
Study design
Consider key factors for effective study design
PMCF
PMCF
Investigate PMCF study design and how to implement PMCF
Who is this course for?
This course is for professionals who are involved with clinical investigations in industry, consultancy, agencies, notified bodies, and within CROs. Delegates may include the following departments and job titles:
- Regulatory affairs
- Clinical development
- Medical writing
- Quality
- Engineers
- Scientists
Find out more about online academies...
MDTI online academies are perfect for busy professionals as they require just 2 hours per week of your time, and include an interactive forum for you to ask direct questions about challenges you are facing to expert course leaders.
On average, delegates of our online academies said...
4/5
85%
4/5
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.
25% discount on Routledge books
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:
- Medical Device Quality Assurance and Regulatory Compliance
- 医疗器械包装手册第三版
- Medical Device Regulatory Practices: An International Perspective
- Nanotechnology in Biology and Medicine: Methods, Devices, and Applications, Second Edition
- And more
