In Europe, products classified as medical devices are subject to stringent regulatory requirements to ensure the product’s safety and performance. To maintain patient safety the EU introduced the EU Medical Device Regulation transforming and modernising the older Medical Device Directive. Whether you are new to regulatory affairs, the EU MDR or are branching out from other areas of the wider medical device industry, this fundamental-level course will detail the EU regulatory requirements throughout the entire product life cycle.
Complemented 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.
During these sessions students will learn through:
- 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
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. 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?
The Medical Device Regulation (MDR)
Learn about the NEW Medical Devices Regulation and how it will impact you
What will change?
Gain a thorough understanding of how the regulation of medical devices will change under the Medical Device Regulation for EU applications
With device classification affecting Clinical, Post Market and risk reporting; get to grips with the classification of your device and the impacts it has on your regulatory strategy
Determine the correct information required for medical device labelling
Understand the role of the Notified Body and Competent Authority
Examine the risk management process for medical devices
How the MDR affects software
Discuss the regulatory challenges of software and methods to tackle these problems
Who is this course for?
- Regulatory Affairs professionals seeking to improve their skills in the regulatory environment.
- 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.
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.
Clinical Trial Manager
Moximed International GmbH
The course was very interactive with lots of opportunities to ask questions. It provided an excellent overview.
Delegates of our live online academies said...
would attend another live online academy
found the course beneficial to their day to day role
would recommend the course to others
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