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Medical Device Development Primer

Medical Device Development Primer broadly explores the five pivotal stages of medical device development. This class focuses on the workflow at each step, from evaluating market opportunities and rigorously assessing concepts to crafting engineering designs and scaling manufacturing. This primer unlocks the secrets of FDA guidances pertaining to process design, qualification, and monitoring. It ends with a look at product risk assessment and reimbursement, summarizing their role in management’s momentous “go”/”no go” decisions. Enroll today to embark on this exciting quest toward groundbreaking medical device development!

Section 1: Market Opportunity Evaluation

Explains how to evaluate the value and opportunity of the product, the user, and the market.

Section 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.

Section 3: Engineering Design

Discusses how required medical device prototype specifications are designed, documented, and tested. 

Section 4: Verification and Validation

Advocates for a process of verification and validation in engineering builds, packaging, labeling, human factors testing, and manufacturing.

Section 5: Manufacturing Transfer

Shows the arduous process of how to move from small scale to large scale production.

Five Takeaways


  1. List the five phases of medical device development in order.
  2. Explain the techniques to effectively evaluate the market opportunity for a novel medical device.
  3. Determine the manufacturing feasibility by analyzing a medical device’s design.
  4. Recommend required prototype specifications needed in medical device design, documentation, and testing.
  5. Explain the FDA validation guidance for process design, qualification, and monitoring.


  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates


  • How long do I have to complete an on-demand course?  You have one year from the date of purchase to complete the course. During that year, you may watch the class an unlimited number of times.
  • What happens if I don’t complete the course in one year?  There are no time extensions. If you want to complete the course, you must purchase it again.
  • How long are the on-demand classes?  Our longest course has a running time of 90 minutes. However, most have a running time of 45 minutes.  The running time is listed for each class on its registration page. The assessment at the end of each course takes between 10-20 minutes to complete.
  • Are there any downloadable class materials? No. All course slides and transcripts remain on your Biotech Primer dashboard, but they are always available for review.
  • What is the format of the on-demand classes?  The online class begins with the class objectives and the course itself and ends with a summary of what you learned. The course is a series of images and text accompanied by a professional voice-over and subtitles. Subtitles are available in 9 languages. The course ends with a quiz to assess your understanding.
  • Can I repeat the course?  You can repeat the course as often as you like within your one-year access.
  • How many times can I take the course quiz?  You have three chances to pass the quiz. A passing score is 75% or higher. You must pass the quiz to receive the class certificate. Your quiz score will be shown on your class certificate.
  • May I share a course I purchased with others?  Each course is to be taken by one individual. If you want to learn as a group, please contact us at for group pricing.

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