Medical Device Executive Certification
Total CPE Credits Included: 12
This program introduces the science, business, and regulatory considerations needed to develop medical devices, including molecular diagnostics, successfully. By completing this industry-recognized Executive Certification, you will distinguish yourself in the medical device industry, opening up new career opportunities and enhancing your professional credibility. To earn your Medical Device Executive Certification, you must successfully complete nine Continuing Professional Education (CPE) courses and pass a final exam. Register today and increase your medical device development knowledge to get ahead in your career!Â
Course 1: The Biology of Biotech
Provides a comprehensive understanding of DNA, proteins, and cells, explaining how they are manipulated to create innovative therapies and diagnostic tools.
CPE Credit: 2.0
Course 2: Diagnostic Development Primer
Navigates the complex world of the diagnostic approval pathways for both IVD and LDTs and give s detailed description of the regulatory requirements for Class I, II and III dignostics.
CPE Credit: 1.5
Course 3: Diagnostics’ Role in Medicine Today
Defines the groundbreaking field of qualitative and quantitative biomarker measurements that help identify diseases, select treatments, and monitor chosen therapies.Â
CPE Credit: 1.0
Course 4: DNA-Based Diagnostics Primer
Highlights the purpose and usage of DNA-based diagnostics, including PCR, microarrays, next-generation sequencing, and microRNA diagnostics.
CPE Credit: 1.0
Five Takeaways
- Develop a comprehensive understanding of biomarkers, such as DNA, RNA, and proteins, and how various molecular diagnostics use them to
diagnose disease. - Explain the qualitative and quantitative measurements (specificity, sensitivity, false positives, and false negatives) used by medical devices to assess disease.
- Recognize the regulatory differences between Class I, II, and III medical devices.
- Enumerate the five phases of medical device development and recommend the prototype specifications needed for design, documentation, and testing.
- Summarize the challenges of launching a new medical device in terms of marketing, sales, reimbursement, and manufacturing scale-up.
Course 5: Protein-Based Diagnostics Primer
Covers protein-based diagnostics commonly used in disease detection in research and clinical settings, focusing on ELISA, bead immunoassays, lateral flow assays, and chromatography technologies.
CPE Credit: 1.0
Course 6: Diagnostic Measurements Primer
Demonstrates the importance of direct and indirect measurements and explains what it takes to secure diagnostic approval by highlighting acceptable measurement thresholds.
CPE Credit: 1.0
Course 7: Medical Device Commercialization Primer
Reveals best practices for business preparations, sales, marketing, and reimbursement—ensuring corporate-wide readiness and effective healthcare promotion.
CPE Credit: 1.5
Course 8: Medical Device Development Primer
Explores the five pivotal stages of medical device development, focusing on the workflow during each step.
CPE Credit: 1.5
Course 9: Medical Device Approval Primer
Provides insight into the FDA and EMA organizational structure and approval pathways, such as 510(k), De Novo 510(k), PMN, and PMA.
CPE Credit: 1.5
Features
- 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