Gain a deeper understanding of clinical evaluations and investigations to navigate the MDR and ensure compliance
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 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 Regulation.
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, delivered in bitesize sessions of 1.5-3 hours online.
Over 2 weeks students will learn through:
- Live interactive bitesize sessions
- 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 lifesciences-training@informa.com.
What will you learn?
Clinical evaluation reports
Clinical evaluation reports
Practical guidance for constructing a clinical evaluation report (CER) with medical writing advice
The Medical Device Regulation (MDR)
The Medical Device Regulation (MDR)
Discuss and evaluate the impact of the new Regulation on clinical evaluations and investigations to ensure you remain compliant and can manage the transition smoothly
Post-market surveillance & risk management
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
Post-market clinical studies
Assess post-market clinical studies for existing products and examine how requirements will change with the new Regulation
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
- Quality
- Engineers
- Scientists
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.
