Master Medical Devices Registration in the USA
Manage medical devices regulatory activities in the USA
Updated on Sep, 2023
Language - English
Course Description
Master medical devices registration in the most important and biggest market ever in the world, the market of the USA, this market could be missed by any pharmaceutical or healthcare company, all the pharma industry professional 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 a regulatory affairs professional you are responsible for bringing up to more than half of the revenue for such a company on one hand while on your other hand you are dealing with the second powerful tool of the medical devices, as medical devices registration time frame is shorter than the pharmaceuticals, its 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 the USA.
Dear pharma industry future professionals, let us start our interesting journey towards medical device registration in the states, we will travel together to the states, meet the health authority there "FDA", and explore its requirements for registration, renewal, and variations, let us get our FDA approval and place our products there.
In this course, we will cover all topics related to medical devices in the USA, starting from the requirements, interim regulations, classification, verification, and special conditions, and weavings
And finally, congratulations to you for mastering medical device registration in the USA 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 the USA
Manage medical devices regulatory activities in the USA
Master the huge market of the USA
Place your medical devices in the USA market
Prerequisites
What are the prerequisites for this course?
Just the PC and welling to stand out of the crowd
Curriculum
Check out the detailed breakdown of what’s inside the course
Master Medical Devices Registration in the USA
11 Lectures
-
Introduction
16:10
16:10
-
FDA overview
15:47
15:47
-
The process flow
15:58
15:58
-
Classification summary
14:30
14:30
-
FDA interface
16:09
16:09
-
510K clearance
16:28
16:28
-
SE/510K clearance
17:41
17:41
-
PMA
12:01
12:01
-
QMS
09:46
09:46
-
Labelling
06:55
06:55
-
Pharmacovigilance
15:10
15:10
Instructor Details
Zahra Hassan Sobhy
This is Zahra Hassan, I'm a pharmacist, with almost 10 years of experience in the pharma industry, my experience is extended to cover the regulatory affairs field, which deals with registration and granting health authorities approval for health products, including medicines, medical devices, over the counter products "OTC", such as food supplements, and cosmetics as well.
This is in addition to the quality compliance, control, and assurance for these health products, and also ensuring product safety through pharmacovigilance activities.
I have been practicing all these professions for 10 years covering 20 countries, across the regions of the Middle East, Africa, Levant, and Turkey.
During my career journey, I gave myself lots of credits by postgraduates studies
Msc of pharmacovigilance Bordeaux university France
MBA, Chiffley buisneiss school , Australia
Dual Diploma of regulatory affairs "pharmaceutical and medical devices" RAP society, USA.
Certified lead auditor
currently enrolled in the Ph.D. program of pharmacovigilance Bordeaux university France
Despite the fact that postgraduate studies for sure will add to the profile, but the practice is something else, in the begging of my career journey I was chasing professionals asking for private lessons after work to gain practical experience from them, and it was not for free, I used to make this deal with many professionals as I can to get as much diverse experience that I can gain, in addition, I used to follow national and international pharma industry events attending, then participating from my own pocket. This simply happens when you follow your passion.
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