Course description
Following its ratification by the European Parliament, the Medical Devices Regulation will constitute major changes for the industry and is expected to become fully applicable in mid 2020. This 2-day introductory-level training course will examine the requirements outlined in the new Regulation as well as the existing Directive.
Major topics you will examine include classification, conformity assessment routes, risk management, post marketing adverse event reporting and labelling. Delegates will learn which regulations directly apply to their product and what steps need to be taken to achieve full compliance and ensure patient safety.
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Suitability - Who should attend?
- 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 Trials, Marketing and others)
- Anyone wishing to update their knowledge on EU regulatory affairs
Training Course Content
- Learn about the NEW Medical Devices Regulation and how it will impact you
- Gain a thorough understanding of how the new Regulation will change future EU applications
- Learn how to classify medical devices
- 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
- Discuss the regulatory challenges of software and methods to tackle these proble
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Reviews
Average rating 5
I was looking for a course which would inform and prepare me for the new MDR. The fact that we could ask questions that arose at any time was great; I enjoyed this course immens...
The fact that it was a small group gave us the opportunity to discuss everything with good informal contact with the trainer.
Expenses
£1,595 +20% VAT = £1,914
The course was very interactive with lots of opportunity to ask questions. It provided an excellent overview.