Master medical devices registration in the USA
Master medical devices registration in the USA, available at $39.99, has an average rating of 3.65, with 11 lectures, 11 quizzes, based on 12 reviews, and has 55 subscribers.
You will learn about 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 This course is ideal for individuals who are All levels of the pharma industry, starting from the fresh graduates till the highly professionals It is particularly useful for All levels of the pharma industry, starting from the fresh graduates till the highly professionals.
Enroll now: Master medical devices registration in the USA
Summary
Title: Master medical devices registration in the USA
Price: $39.99
Average Rating: 3.65
Number of Lectures: 11
Number of Quizzes: 11
Number of Published Lectures: 11
Number of Published Quizzes: 11
Number of Curriculum Items: 22
Number of Published Curriculum Objects: 22
Original Price: $124.99
Quality Status: approved
Status: Live
What You Will Learn
- 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
Who Should Attend
- All levels of the pharma industry, starting from the fresh graduates till the highly professionals
Target Audiences
- All levels of the pharma industry, starting from the fresh graduates till the highly professionals
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 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 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 the 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, 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, with lots of innovations and 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 toward 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, 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.
Course Curriculum
Chapter 1: Introduction
Lecture 1: Introduction
Chapter 2: FDA overview
Lecture 1: FDA overview
Chapter 3: The process flow
Lecture 1: The process flow
Chapter 4: Classification summary
Lecture 1: Classification summary
Chapter 5: FDA interface
Lecture 1: FDA interface
Chapter 6: 510K clearance
Lecture 1: 510K clearance
Chapter 7: SE/510k mandate
Lecture 1: SE/510K clearance
Chapter 8: PMA
Lecture 1: PMA
Chapter 9: QMS
Lecture 1: QMS
Chapter 10: Labelling
Lecture 1: Labelling
Chapter 11: Pharmacovigilance
Lecture 1: Pharmacovigilance
Instructors
-
Dr. Zahra Hassan
Pharma industry expert
Rating Distribution
- 1 stars: 2 votes
- 2 stars: 2 votes
- 3 stars: 3 votes
- 4 stars: 4 votes
- 5 stars: 1 votes
Frequently Asked Questions
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