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Medical Device and Diagnostics

Blue capsule medicine pill production line, Industrial pharmaceutical concept.

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All Access Subscriptions

Take advantage of 100+ hours of on-demand learning with our subscription packages. Gain a thorough understanding of the science, business, and regulatory considerations of the biopharma and medical device sectors. Learn the most at the lowest price.

Micro Class Subscription

This subscription includes all Micro Classes in the following certificate programs at an 85% discount with unlimited access to over forty hours of life science training…

40+ Hours

Recorded Signature Course Subscription

This subscription includes all Recorded Signature Courses in the following certificate programs at 75% discount with unlimited access to over sixty hours of life science training…

60+ Hours

All Access Subscription Bundle

This subscription includes all Micro Classes and Recorded Signature Courses in the following certificate programs with an additional $400 discount and unlimited access to over one hundred hours of life science training…

100+ Hours

On-Demand Courses

Medical Device and Diagnostics for Non-Scientists

Increase your fluency in medical device technology and regulations to work more effectively with industry clients, colleagues, and regulators.

Diagnostic Development Primer

Diagnostic Development Primer begins by examining the big picture; the roles of U.S. government agencies and their regulatory authority over in vitro diagnostics (IVD) and laboratory-developed tests (LDT)…

85 minutes

Diagnostics’ Role In Medicine Today 

Diagnostics’ Role In Medicine Today introduces the ever-expanding molecular diagnostics industry. Learn the science behind personalized medicine, and how companion diagnostics help…

85 minutes

DNA-Based Diagnostics Primer

DNA-Based Diagnostics Primer explains the role and uses of PCR, microarrays, gene sequencing, and microRNA technology as diagnostics. Gain entry into the fast-paced field of DNA-based diagnostics by understanding…

85 minutes

Protein-Based Diagnostics Primer

Protein-Based Diagnostics Primer focuses on antibodies: what they are, where they come from, and how they work.  Covering sandwich and bead immunoassays, multiplexed assays, lateral flow assays, and chromatography.

40 minutes

Diagnostic Measurements Primer

Diagnostic Measurements Primer surveys the measurements used to assess a diagnostic’s accuracy. A test must achieve a certain level of accuracy before receiving regulatory approval. 

47 minutes

Medical Device Commercialization Primer

Medical Device Commercialization Primer explains the medical device approval process from initial regulatory submission through commercialization. Successful regulatory outcomes…

55 minutes

Medical Device Development Primer

Medical Device Development Primer provides a detailed look at the five stages of medical device development, including market opportunity evaluation, concept evaluation, engineering design…

57 minutes

Medical Device Approval Primer

Medical Device Approval Primer explains how medical devices are regulated in the United States. Device classification and each classification’s differing approval pathways…

85 minutes

Recorded Medical Device Development Immersion

Medical Device Development Immersion showcases the fascinating aspect of medical device development. Beginning with an overview of the dynamic medical device industry, this course quickly…

85 minutes

“We loan biotech companies money to fund projects, and we really have to understand their business in order to make decisions about our loans. The Medical Device Development Primer course gave me that understanding.”

Director of Loans

“DNA Based Diagnostics Primer and Diagnostics Measurements Primer got me to where I can speak confidently about the subject of molecular diagnostics and understand it enough to market it.”

Director of Communications

“People in my company said that Biotech Primer is a thorough, trusted, good all-around training company that breaks down information into digestible bits. That recommendation was good enough for me. I took the Medical Device Commercialization class, and it did not disappoint.”

Finance Manager

Launch Yourself Into The Future.

From foundational science to pharmaceutical drug development, business dynamics, medical device innovation, and global regulatory standards, our expert-led courses are designed to equip non-scientists with the knowledge and skills needed to thrive in the biotech industry.

Unlock the world of biotechnology with Biotech Primer’s comprehensive courses.


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