18-Month Access
1-Year Access
12 Courses
9 Courses
13.5 CPE Credits
12 CPE Credits
Final Exam + Verified Certificate
Final Exam +
Verified Certificate

List of Courses

The Biology of Biotech

Highlights the ways DNA, proteins, and cells are harnessed to create cutting-edge treatments and diagnostics

Diagnostic Development Primer

Offers a comprehensive regulaotry guide to IVD and LDT approval pathways for Class I-III diagnostics

Diagnostics’ Role In Medicine Today

Surveys the critical role of diagnostics that power smarter, targeted healthcare.

DNA-Based Diagnostics Primer

Explains DNA-based technologies, including PCR, microarrays, NGS, and microRNA diagnostics that detect, analyze, and guide critical decisions in research and healthcare.

Protein-Based Diagnostics Primer

Showcases protein-based technologies, including ELISA, immunoassays, and chromatography, that detect, analyze, and inform critical decisions in research and healthcare.

Diagnostic Measurements Primer

Explains the impact of measurement accuracy, sensitivity, and specificity on FDA approval for medical devices.

Medical Device Commercialization Primer

Explains the Class I-III approval pathways, launch strategies, and post-market responsibilities to ensure commercial success.

Medical Device Development Primer

Explores the five critical stages that shape successful medical device development.

Medical Device Approval Primer

Explains FDA and EMA approval pathways, device classifications, and global quality standards to ensure the right regulatory strategy.

FAQ

What are my options for purchasing an Executive Certification?

You have two Executive Certification purchasing options:

  1. Purchase an individual Executive Certification for $2850.
  2.  Purchase a yearly subscription for $359 per month and gain access to all four Executive Certifications.
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WHAT PEOPLE ARE SAYING

"I’ve been involved with med tech companies, so I had picked up on the development path in general, but the Medical Device Development Immersion course was really helpful in providing a full context and clarifying the details. All your [Biotech Primer] courses are really solid...

Elayne Wandler

Director, Programs, Canada’s Digital Supercluster

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