Medical Device Regulations

Learn about the medical device industry and how to bring new products to market 510K, PMA, De Novo, ISO13485 and beyond!

4.03 (139 reviews)

Udemy

platform

English

language

General Health

What you will learn

Learn how medical devices go from idea to product

Understand the 510K and PMA submission process for medical devices

FDA regulatory pathways including 510K, PMA, De Novo, IDE, HDE

Risk management and quality in device development

Learn how to research new devices and companies

Understand medical device career paths and opportunities

Why take this course?

The medical device industry is growing rapidly, providing great opportunities for innovators, experts and entrepreneurs. This course will provide a detailed overview of the way in which new devices go from concept to product, providing you with a starting point to develop a deep understanding of this complex and fast-moving business space.

We will cover all of the key components of bringing a new device to market, including:

Paths to Market, including the 510K, PMA, HDE and other commonly used pathways
Clinical trials of medical devices, including IDE, submissions, records and reporting
Risk management and quality in device development

During this course we will also cover the publicly available information sources that will enable you to research device companies and understand their value. We will cover medical device databases that allow you to research marketed medical devices. We will cover clinical trial databases that allow you to research planned and ongoing trials of medical devices. Links to these freely available resources will be provided.

This course will be a valuable resource for anyone interested in developing their basic knowledge of the medical device industry. For students and recent graduates in medical device engineering, this course will help you develop a knowledge of the industry and the regulatory steps that companies use to bring new innovations to market. For project managers, this course can help you to learn about this industry and equip you to manage medical device development projects. For professionals working in related fields, this course will provide an overview of the medical device industry.

Reviews

October 20, 2023

Good high-level overview. Found first couple of sections repetitive. Instructor indicated several times that links would be provided in resources, but they were not and the links shown on slides were not always valid paths - but it is a good exercise to find info on FDA website yourself.

Robert

October 20, 2023

Some aspects are meager and is really a top-level review, but overall course is good, but not complete. Video Quality -The lip-smacking is most annoying -Far too many "err, err's. -The vocal level goes from loud to almost a whisper, so I had to keep adjusting the volume. Many of the links are not within the side pannel and we have to manually type into a browser.

Jonattan

July 10, 2023

Content is not bad but it's very annoying to hear "uh" every other word and even at 2x speed the audio is slow.

May 31, 2023

Good resource! I will definitely review this again. I did not like that there are no quizzes and he did not provide clickable links for the referenced and mentioned FDA links. You may want to skip the first 2 sections and go straight to the meaningful content in the later sections.

Jayesh

March 14, 2023

The course is really good. It has covered in depth know about MDR for US. This is good course for beginners.

Lungile

January 8, 2023

Somewhat. Based heavily on the US legislation and processes which don't apply to me, but good overview nonetheless.

Shiva

January 3, 2023

The instructor speaks very slowly. General information is only available. it could have been more in-depth...

Surjeet

November 16, 2022

I found it really good as it gives an overall idea of medical device development under the required regulations. It's a good deal to learn most important things in just 7 hours.

Frank

September 15, 2022

First part was very dry and unnecessary for what I was looking for in the program. However, all successive chapters are more of what I was looking to gain in understanding

Violet

June 23, 2022

This course provides comprehensive training in the area of Medical Devices, starting with a broad overview of the industry and going into detail on specific topics of interest.

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Medical Device Regulations - Distribution chart