Clinical Data Evaluation for Medical Devices

CLASSROOM TRAINING

Course Overview

 

If you are actively involved with the creation and maintenance of clinical evaluation files, our 2 day training course will enhance your level of understanding on the application of key methods to ensure that the requirements of the new MDR are met.

In 2016, MEDDEV 2.7/1 rev 4 was published, bringing more stringent requirements for complying with clinical data evaluation. These requirements were not well understood by the industry and with the looming Medical Device Regulation (MDR), it has never been more imperative that you get clinical data right.​

Over the 2 days, our expert tutors will give you the necessary skills to ensure all the requirements of the law are met and provide an insight into how the clinical evaluation is integrated with risk management, post-market surveillance, the periodic safety update report, the summary of safety and clinical performance, trending and the CAPA system.

Our team performs clinical evaluation reviews for notified bodies so we can offer you insights into common pitfalls. 

By the end of this practical course, you will be able to understand the theory of planning, conducting and producing a clinical evaluation report which will meet the requirements of the law.

Course Agenda

▪    Practical use of MEDDEV 2.7.1 rev4

▪    The limits of MEDDEV 2.7.1 rev4

▪    The additional requirements imposed by the MDR 

▪    Methods of real-world literature review

▪    Techniques for establishing that sufficient Information is presented 

▪    Post-market requirements

▪    How to address continuous updates in a practical way

▪    Conducting post-market clinical follow-up

▪    Where clinical evaluation fits in the legal framework 

Day 1: 8:30am - 16:30pm

Day 2: 9:00am - 16:30pm

The certification you will earn can be used to demonstrate your knowledge to your employers and Notified Bodies.

Learning Style

This is a classroom based course filled with practical and interactive activities to embed your learning. 

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Who should attend?

This two day training course has great value for anyone involved in 

implementing or maintaining clinical evaluation file. 

▪    Internal Auditors

▪    Quality Engineers

▪    Quality Managers

▪    Regulatory professionals

▪    Manufacturing Engineers

▪    Research and Design Engineers

▪    Quality Assurance professionals

What will I receive?

▪    Lunch

▪    Refreshments 

▪    Training course notes, slides and handouts 

▪    Clinical evaluation training course certificate 

Our team Is on hand to support you with any B&B bookings if required. 

On-site Training

Any of our courses can be delivered on-site at your premises. 

Contact us today to find out more.