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Introduction to Regulatory Affairs for Medical Devices

PTI
Course summary
2 days
1,595 GBP excl. VAT
English
Berlin, Brussels, City of London
Next available date: 21/09/2020 - Brussels
Professional Training

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.

Want to get both introduction and advanced level training on this topic?

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

Expenses

£1,595 +20% VAT = £1,914

About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...


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Contact info

PTI

London

 Show phone number
http://www.pti-global.co.uk


Reviews

Average rating 5

Based on 5 reviews

Clinical Trial Manager, Europe, Moximed International GmbH
(5)
The course was very interactive with lots of opportunity to ask questions. It provided an excellent overview.
Scientific Affairs European Manager, Moximed International GmbH
(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 immensely.
Regulatory Affairs Officer, Barco N.V
(5)
The fact that it was a small group gave us the opportunity to discuss everything with good informal contact with the trainer.
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Reviews
Course rating
(5.0)
Based on 5 reviews
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