How to Market Medical Devices in the U.S.
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How to Market Medical Devices in the U.S.

Register with the FDA
3.5 (5 ratings)
Instead of using a simple lifetime average, Udemy calculates a course's star rating by considering a number of different factors such as the number of ratings, the age of ratings, and the likelihood of fraudulent ratings.
19 students enrolled
Created by Quality Remedy
Last updated 11/2015
English
Current price: $10 Original price: $45 Discount: 78% off
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Includes:
  • 41 mins on-demand video
  • Full lifetime access
  • Access on mobile and TV
  • Certificate of Completion
What Will I Learn?
  • Plan to register medical devices with the United States FDA
  • Classify their product and identify 510(k) predicate devices
  • Grasp FDA review timelines and common questions
  • Outline a product development strategy
View Curriculum
Requirements
  • Have a basic understanding of their device patient population
Description

Description

Understanding the FDA's regulatory system is the first objective for device manufacturers looking to sell in the U.S. The 510(k) Premarket Notification submission should be prioritized when developing a medical device. This pathway provides marketing clearance and the ability to sell your medical devices in the U.S. Before sales can occur companies have two options: 510(k) Premarket Notification (unless exempt); or Premarket Approval (PMA) approval. PMA’s are resource intensive, and so 510(k)’s are the ideal submission type.

Areas Covered in the seminar:

  • U.S. FDA medical device methodology
  • Class I, II, and III devices
  • How to identify Class I, 510(k)-exempt devices
  • The three types of 510(k)’s
  • 510(k) determination - new; and substantially modified
  • Intended Use statement – key insights
  • How to locate predicate devices
  • How to interact with the FDA
  • FDA Review timelines
  • Post-submission review
  • Common questions by the FDA

Who will benefit:

  • Executive Management
  • Product Management
  • Engineering
  • Regulatory Affairs personnel
  • Quality Assurance personnel
Who is the target audience?
  • Innovators and Healthcare Entrepreneurs
  • Innovators and Healthcare Entrepreneurs seeking insights into the FDA device regulations and quality expectations.
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Curriculum For This Course
Expand All 5 Lectures Collapse All 5 Lectures 40:40
+
Classification
1 Lecture 10:33
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Substantial Equivalence
1 Lecture 04:33
Identify a predicate device
04:33
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Types of 510(k)
1 Lecture 07:12
Prepare 510(k) submission content
07:12
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Labeling & Performance Testing
1 Lecture 04:53
Allocate resources for product development
04:53
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Timelines & Important Considerations
1 Lecture 13:29
Save resources by utilizing key insights
13:29
About the Instructor
Quality Remedy
3.5 Average rating
5 Reviews
19 Students
1 Course
Medical Device Start-up Solutions

QUALITY REMEDY provides regulatory support, quality management consulting, and product development solutions to medical device companies. As a regulated industry, medical device development is a complex world. This sector requires strict processes, robust records, internal/external auditing and much more in order to demonstrate product safety and effectiveness. Let us help you abide by the constantly evolving guidelines.