Medical Device Development

  • Course Price: $150
  • BIO Member Price: $120
  • Course Run Time: 57 minutes
  • Course Level: Level 2 - General
  • Completion Period: 2 week

Medical Device Development provides a detailed look at the five stages of medical device development including: market opportunity evaluation, concept evaluation, engineering design, verification/validation and manufacturing transfer. If you are an engineer, manufacturer, information technologist, investor or someone who finds themselves in development this course will broaden your knowledge of the entire development process.

Suggested Prerequisites

Diagnostics’ Role in Medicine Today 

Take in Conjunction with: Medical Device Overview and Regulation

  1. Understand the importance of the five phases of medical device development.
  2. How to evaluate market opportunity.
  3. Determine the manufacturing feasibility based on a medical device's design.
  4. Learn the required prototype specifications needed in device design, documentation, and testing.
  5. Appreciate the process of device scale-up production.
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
Phase 1: Market Opportunity Evaluation
Explains how to evaluate the value and opportunity of the product, the user, and the market.
Phase 2: Concept Evaluation
Determines the feasibility of the medical device's conceptual design and how that blueprint is used to map out the key steps in product design.
Phase 3: Engineering Design
Discusses how required medical device prototype specifications are designed, documented, and tested.
Phase 4: Verification & Validation
Advocates for a process of verification and validation in engineering builds, packaging, labeling, human factors testing, and manufacturing.
Phase 5: Manufacturing Transfer
Shows the arduous process of how to move from small scale to large scale production.
Final Quiz
Course Evaluation
Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation
You have two weeks from time of purchase to complete any of the online courses. For example, if you purchase the course at 9 am on Saturday, the course will close at 9 am 14 days later.

You can pay an additional fee for an extension.

Our online courses are between 40 minutes and 85 minutes in length. We suggest allowing 20 minutes to take the end of the course quiz and 10 minutes for the course evaluation. 

Yes, each course has an accompanying pdf that contains all of the presented course information. You will be able to download the pdf once you have registered for the course. 

There are no refunds if you decide to not take the course once you have registered. 

The online courses are fully animated with a professional voice-over. Each course begin with an overview of what you will learn, the course itself, and then ends with a course quiz to assess your understanding.

You can repeat the course as often as you like within your two week run time.

You have two chances to pass the quiz. A passing score is 70% or higher. 

Each course is to be taken by one individual. If you would like to take our online courses as a group, please contact Stacey Hawkins at This email address is being protected from spambots. You need JavaScript enabled to view it. for pricing.

There are three requirements to receive your course certificate. 1. You must view the entire course. 2. You must pass the course quiz with a 70%. 3. You must complete the course evaluation. You can download and print your certificate from your dashboard.

Before moving on to the next section of our on-demand, online courses, all slides within a section must be viewed.

There is an easy way for you to see which slides you have completed and not completed in the course. Look at the menu on the left side of the course- the slides that have been seen are darkened and the slides that have not been seen are light. 


Certificate Requirements
  • View the entire course
  • Pass course exam with a 70 percent
  • Complete the course evaluation