To improve patient safety the EU Medical Device Regulation puts a greater emphasis on sufficient clinical evidence to provide safety, especially for Class III products. As a result, manufacturers need a more robust clinical plan to meet the new requirements, without an effective clinical strategy more costly clinical investigations are needed.
But what are the clinical requirements and how do I meet them?
How can I leverage my current data, literature searches and equivalence to meet the clinical data needs?
What is required to perform a trial?
This interactive 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 EU MDR.
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.
During this course 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?
Clinical Evaluation Reports
Practical guidance for constructing a clinical evaluation report (CER) with medical writing advice
Impact of the Medical Device Regulation (MDR)
Discuss and evaluate the impact of the new regulation on clinical evaluations and investigations to ensure you remain compliant while managing the transition smoothly
Post-Market Surveillance & Risk Management
Examine how the clinical evaluation report is linked to post-market surveillance and the risk management plan
Post-Market Clinical Studies
Assess post-market clinical studies for existing products and examine how requirements will change under the MDR
Who is this course for?
This course is aimed at professionals who are responsible for or involved in clinical evaluations and investigations in industry, consultancy, agencies, notified bodies and within CRO’s and include the following departments and job titles:
- Regulatory affairs
- Clinical development
- Medical writing
Oticon Medical AB
Time-efficient course, providing all necessary basic information about clinical evaluation and the related regulatory requirements. Also, the templates provided are useful
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.
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
- Design Controls for the Medical Device Industry, Third Edition
- Usability Testing of Medical Devices
- Nanotechnology in Biology and Medicine: Methods, Devices, and Applications, Second Edition
- And more