Medical Device Development

medical device development course

This is a basic online course about Medical Device Development for new professionals or those just  entering the field.  The material supplies a detailed overview of medical device development from a realistic industrial perspective using recorded lectures and slides. The processes used in companies to conceive and develop devices will be explored from a research, regulatory, clinical, QA/QC, marketing, engineering, and legal perspective under the umbrella of project management techniques. The course is 100% online and modeled after the “Medical Device Development”  class taught at the New Jersey Institute of Technology since 2009.  Students in this course will gain a broad  overview of all aspects for the early phases of device design.  This course assumes no prior knowledge of  medical devices or their development.  New students should be able to understand the entire content with  no prior background.


Medical Device Development Course Objectives:

  • Function as a member of a medical device project team
  • Understand the various disciplines involved with medical device development
  • Know the roles that different departments and professions play in medical device development

Who should take this course?

  • Biomedical Engineering (or other STEM majors)
  • Academics that need to understand the difference between Industry and Academia
  • Physicians that have a medical device idea and wish to know the basics of how to get started
  • Graduate and Undergraduate students whose schools do not offer courses like this one
  • Medical Device Engineers with 0 to 2 years of experience that need a basic education about the various roles in device development

Medical Device Development Course Outline:

  • Introduction – Medical Device Development: Academia vs. Industry
  • Project Management 101 – How corporations manage projects
  • Pre-clinical Device Development – Research projects
  • Regulatory considerations for medical device development
  • Manufacturing, Quality Control, and Quality Assurance
  • Business 101 – What makes corporations tick and research labs tock
  • Marketing medical devices, and the basics of sales forces
  • Clinical trials, CRA’s, and CRO’s
  • Design Controls 101: DHF, Proposal, DDP, Inputs, Outputs, Specifications
  • Design Controls 101: Verification, Validation, Transfer
  • Risk Analysis: FMECA, Risk analysis document
  • Organization types, putting together project teams, Project Management: The Sequel
  • Consultants – Role in medical device development, Advamed, Anti-kickback statute, Confidentiality

What you get:

  • Unlimited time access to 30 recorded online lectures (~ 7 hrs of content)
  • Basic template documents for common device development processes
  • Access to a medical device forum for discussing/asking questions to the instructor
  • Free updates to course material

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13 thoughts on “Medical Device Development

  1. taha alshakhes says:

    i am working in medical devices developement in one saudi medical devices industry and would like to attend basic course for medical device developement


    taha ahmed alshakhes
    saudi arabia
    mobile : 00966554629362

    1. Josh says:

      Excellent, Taha. Go ahead and click the link to begin taking the course online.

  2. I am newly appointed as drug inspector in the LDC listed country Bangladesh.I would like to attend the basic course of medical device development for free.With due respect I am requesting you to consider me as trainee.

    1. Josh says:

      You are accepted as a trainee. Click the link below to begin the course:

      –Dr. Simon

  3. Sunil Kumar Rathore says:

    Dear Sir,

    I m working for medical devices company in India I m interest to doing this course need your guidance


    1. Josh says:

      Not really sure why I am getting a lot of these comments from eastern countries that are asking to take the course. Just take the course. It’s up and ready to go. There is no need to ask for permission or guidance. It’s all online and it’s all there and ready. Go ahead and click the link and begin.

      –Dr. Simon

  4. Daniel Takele says:

    i am working in Ethiopian food, medicine and healthcare administration and control authority in one team of medical devices registration and would like to attend basic course for medical device development . I ‘m interested to doing this course and i need your guidance
    thank you

    1. HENOK HAILU says:

      I am working in EFMHACA at health institution inspection Team. I want this training to improve my knowledge related to medical device defects and other basic areas concerning to medical device regulation.

      1. Josh says:

        All you have to do is click the link and begin.

  5. Allison says:

    Hello, i would like to take the course as well. Can you provide a coupon code to waive the $300?

    1. Josh says:

      I am sorry, but ultimately this is also a business and some compensation is needed. The rate is quite cheap when you compare it to most any other similar course.

  6. André Ventura says:

    Dear Dr. Josh,

    I would like to know if we have a certificate after these courses proceeding with the registration through your website ( What is its difference comparing with Udemy website?

    Thank you for your attention.
    Best regards,
    André Ventura

    1. Josh says:

      Andre, yes, every course on this site gives a certificate of completion once you have checked off all of the lessons as Done.

      The courses here are exactly the same as the ones on Udemy, except they are cheaper.


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