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.
16 students enrolled
Instructed by Quality Remedy Business / Strategy
67% off
Take This Course
  • Lectures 5
  • Length 41 mins
  • Skill Level Intermediate Level
  • Languages English
  • Includes Lifetime access
    30 day money back guarantee!
    Available on iOS and Android
    Certificate of Completion
Wishlisted Wishlist

How taking a course works


Find online courses made by experts from around the world.


Take your courses with you and learn anywhere, anytime.


Learn and practice real-world skills and achieve your goals.

About This Course

Published 11/2015 English

Course 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

What are the requirements?

  • Have a basic understanding of their device patient population

What am I going to get from this course?

  • 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

Who is the target audience?

  • Innovators and Healthcare Entrepreneurs
  • Innovators and Healthcare Entrepreneurs seeking insights into the FDA device regulations and quality expectations.

What you get with this course?

Not for you? No problem.
30 day money back guarantee.

Forever yours.
Lifetime access.

Learn on the go.
Desktop, iOS and Android.

Get rewarded.
Certificate of completion.


Section 1: Classification
Properly classify your medical device
Section 2: Substantial Equivalence
Identify a predicate device
Section 3: Types of 510(k)
Prepare 510(k) submission content
Section 4: Labeling & Performance Testing
Allocate resources for product development
Section 5: Timelines & Important Considerations
Save resources by utilizing key insights

Students Who Viewed This Course Also Viewed

  • Loading
  • Loading
  • Loading

Instructor Biography

Quality Remedy, 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.

Ready to start learning?
Take This Course