Are you ready for the new Medical Device Regulation (MDR)?
Published on May 5th 2017, the final text of the Medical Devices Regulation constituted major changes for the industry. This flexible online course offers students an excellent opportunity to understand the basics of the entire medical device product lifecycle in the context of these updates.
This course will allow you to engage with a leading expert in the field and come to grips with regulatory affairs, quality management systems, risk management, clinical evaluation requirements and general compliance aspects of medical devices.
The new MDR necessitates a degree of transformation for medical devices manufacturers, importers and distributors, including changes to classification and safety and performance requirements for proving compliance, among others. Designed for those new to medical devices, or need a broad overview of the changes resulting from the MDR, this course will cover a variety of major topics to give an excellent understanding of the area.
MDTI online courses are on-demand digital courses developed by our expert faculty providing learning on a range of technical topic areas.
Over 5 weeks students will learn through:
- 9 modules, split up into multiple bitesize recorded videos
- Quizzes to test your knowledge
- Revisiting the content with unlimited access to all 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 contact firstname.lastname@example.org.
What will you learn?
Grasp the changes that the medical device industry needs to implement to remain compliant with the new regulations
Dossier submission procedures
Understand how to submit your documentation to ensure your device is in line with the updated general safety and performance requirements
Requirements for clinical evidence
Familiarise yourself with the stringent clinical evidence requirements and vigilance reporting
Learn to classify your device under the new guidelines
Post-market and surveillance requirements
Understand the post-market and surveillance requirements
Clinical investigations & evaluations
Discover best practice for clinical investigations and evaluations reporting detailed in ISO 14155
Who is this course for?
This course is suitable for professionals who work in the medical device regulatory industry who need to understand the changes in the EU law. Particular areas may include:
- Regulatory Affairs
- Medical Device Development
- Clinical Investigations
- Chief Operating Officer – Doctors & Nurses etc.
- Adverse Events Reporting
- Research & Development
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...
for quality of content
applied content during the course to their role
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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 website www.routledge.com.
Examples of books and eBooks within medical devices include:
- Medical Device Quality Assurance and Regulatory Compliance
- Medical Instruments and Devices: Principles and Practices
- Design Controls for the Medical Device Industry, Third Edition
- Usability Testing of Medical Devices
- And more