BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
Diagnostic Development & Approval
Diagnostic Development and Approval describes the regulatory pathways for different categories of diagnostics, emphasizing the differences between in vitro diagnostics and laboratory-developed tests. Quality system regulations are extensively reviewed. The course ends with a discussion on the economic evaluation of novel diagnostics. Diagnostic Development and Approval helps anyone in the diagnostics industry expand their diagnostics development acumen.
- Discuss the differences in diagnostic oversight by the FDA and the CMS.
- Explain the US regulatory process for in vitro diagnostics with laboratory developed tests.
- Recognize FDA’s Class I, Class II, and Class III diagnostics.
- Summarize the EU diagnostics approval process.
- Discuss the challenges in receiving diagnostic reimbursement in the US.
- View the entire course
- Pass course exam with a 70 percent
- Complete the course evaluation
Learn how to develop and gain regulatory approval for medical devices.
Medical Device Development Immersion is an interactive, two-day preparatory course designed for those who need to better understand all aspects of medical device development.
How Diagnostics Work: DNA-Based Diagnostics explains the molecular science and technology used in a common set of diagnostic tools, including the various types of PCR, SNP chips, next-generation sequencing and microRNA techniques. Gain entry to the fast-paced field of molecular diagnostics by taking this course.
Diagnostics' Role in Medicine Today introduces the ever-expanding molecular diagnostics industry. Diagnostics save lives by helping to pinpoint the exact cause and location of disease. Learn the purpose of each type of diagnostic, the science behind personalized medicine, and how companion diagnostics help doctors prescribe medication and dosage correctly the first time. If you are new to this area of health care, Diagnostics’ Role in Medicine Today will provide a solid foundation on which to build your diagnostic acumen.