Clinical Research for Medical Devices

Comprehensive instruction on the guidelines and methods of clinical research.
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30 students enrolled
Instructed by Dr. Josh Simon Business / Other
$90
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  • Lectures 8
  • Length 2 hours
  • Skill Level Intermediate Level
  • Languages English
  • Includes Lifetime access
    30 day money back guarantee!
    Available on iOS and Android
    Certificate of Completion
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About This Course

Published 5/2015 English

Course Description

This course takes the painfully dry regulations and methods used for clinical trials on medical devices and distills them nicely into a clean overview over the course of an hour. Students will learn about Good Clinical Practices (GCP's) and the regulations that govern clinical trials in the USA and rest of world, such as 21 CFR Parts 50, 56, and 812 and the ICH guidelines. As a "quick hit" to gain knowledge, this course works wonderfully for getting new trainees to hit the ground running. It also serves to increase the knowledge of current Clinical Research Associates, especially those who are soon looking to take a certification exam for clinical research.

What are the requirements?

  • Students will need a general understanding of what clinical trials and clinical research are

What am I going to get from this course?

  • Understand the process for designing and running clinical trials on medical devices
  • Understand the rights of patients and the responsibilities of sponsors and investigators
  • Combine this knowledge with personal experience to pass the various clinical research certification exams
  • Become familiar with Good Clinical Practices (GCP's)
  • Understand and summarize clinical research regulations such as the ICH guidelines and 21 CFR parts 50, 56, and 812

What is the target audience?

  • Clinical Research Associates looking to expand their knowledge
  • Individuals preparing to test for a clinical research certification
  • Experienced clinical professionals looking to brush up on regulations
  • Medical Device Project Managers that need to understand the role of clinical research on their team

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.

Curriculum

Section 1: Clinical Research for Medical Devices
06:00

Information about who should take the course and instructor bio.

Article

Discussion forum for the Clinical Research for Medical Devices course

08:57

A brief history of how the current guidelines and regulations for Clinical Research came into being.

13:47

Students will gain a summarized overview of 21 CFR parts 50 and 56 for rules regarding patient informed consent and IRB's.

17:59

Understand the roles played by the Sponsor, Investigator, and Monitors.

11:06

Overview of the different types of clinical trials and various parameters defined for each.

01:28

Explanation of the attached notes to study for Clinical Research certifications.

53 pages

A 50-page e-book that summarizes in bullet point form all of the regulations needed for conduction of clinical research, and those that are most asked about on clinical research certification exams.

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Instructor Biography

Dr. Josh Simon, Medical Device Development Professional

Currently, I am Principal Consultant at Spiral Medical Development and an Adjunct Professor at the New Jersey Institute of Technology. For over 10 years, I have worked in various roles developing medical devices and have touched perhaps hundreds of them in varying capacities from concept to launch.

As someone that loves to give back and feels obligated to teach those that are coming after me in the medical device industry, I have always said that it is important to excel in at least two things. Every day I try to be an example to my coworkers and students by using my experience in research and business to bridge the gap between the two. This usually involves conversations from all perspectives covering project management, medical device product development, marketing, training, and research planning. Being able to explain tough concepts to audiences without background in a subject has been my forte, and I have used it in numerous device companies, sales training classes, CME, and Grand Rounds presentations around the world. Going the other way, I have conveyed crucial business strategies to motivate product development and research professionals both in industry and academia. While my formal training is in general business and Biomedical Engineering with specific interest in bone tissue engineering and biomaterials, I see myself as a translator. The languages of business and science are not often mutually understood, and I act as the intermediary.

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