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Master Medical Devices Registration in Europe

person icon Zahra Hassan Sobhy

4

Master Medical Devices Registration in Europe

Manage medical devices regulatory activities in the European market /Be the expert of EU market

updated on icon Updated on May, 2024

language icon Language - English

person icon Zahra Hassan Sobhy

English [CC]

category icon Business,Industry,Pharmacy

Lectures -12

Resources -5

Duration -2.5 hours

4

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Course Description

Master medical devices registration in the most important and biggest market ever in the world, the European market, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professionals understand very well the weight of this market, how huge it is, and what is the expected revenue out of it.

This course will equip you with two powerful tools to invade the pharma industry, as regulatory affairs professional to achieve the company revenue from this interesting part of the world on one hand while on your other hand you are dealing with the second most powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, it is almost half the time frame of the pharmaceuticals.

To register a medical device you will need only 6 months, 3 months for variation, and 2 to 1 month only for renewal.

So from a business point of view, you can place your product in the market quite faster and start earning your revenue quite fast also, moreover, the medical devices world is highly dynamic and innovative, compared to the pharmaceuticals, lots of innovations different versions of the same medical device could be played within the potential market of Europe.

Dear pharma industry future professionals, let us start our interesting journey towards medical device registration in Europe, we will travel together to Europe, meet the health authority there "MHRA", and explore its requirements for registration, renewal, and variations, let us place our products there.

In this course, we will cover all topics related to medical devices in Europe, starting from the requirements, interim regulations, classification, verification, and special conditions.

Then we will go deeper to see the actual forms, and templates as usual I keep the theme of the Pharma Academy that it comes to you "From Practice", and prepare the submission dossier together, and ensure its verification, of the medical, and interact with the actual MHRA gateway for the submission. 

and we will end our journey, by landing the department of custom clearance, tracking /tracing system, barcoding, 2DMatrix for all the shipments planned for the European market importation.

And finally, congratulations to you for mastering medical device registration in the European market, and see you soon in the pharma industry my dear colleagues.

Who this course is for:

  • All levels of the pharma industry, starting from the fresh graduates till the highly professionals

Goals

What will you learn in this course:

  • Master medical devices registration in Europe

  • Manage medical devices regulatory activities in Europe

  • Place your medical devices in the market of Europe

  • Master the European market by medical devices

Prerequisites

What are the prerequisites for this course?

  • Just the PC and welling to stand out of the crowd

Master Medical Devices Registration in Europe

Curriculum

Check out the detailed breakdown of what’s inside the course

Master Medical Devices Registration in Europe
12 Lectures
  • play icon Introduction 08:00 08:00
  • play icon Definition 17:48 17:48
  • play icon EMA Regulatory Pathway 23:36 23:36
  • play icon Borderline products 07:47 07:47
  • play icon Stakeholders 16:20 16:20
  • play icon EMA MD Regulations 17:44 17:44
  • play icon CE Mark 07:39 07:39
  • play icon Free Sale Certificate 16:04 16:04
  • play icon New EMA regulations 14:48 14:48
  • play icon System/procedure packs 20:22 20:22
  • play icon Tracking/Tracing 11:21 11:21
  • play icon EUDAMED 09:05 09:05

Instructor Details

Zahra Hassan Sobhy

Zahra Hassan Sobhy


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