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Medical Device and Diagnostic Courses

Learn the scientific, regulatory, and business considerations needed to develop and bring a medical device / diagnostic through the approval process. 

On-Demand and live courses 

Choose from our on-demand, online, and onsite master courses. All training is developed and delivered by industry experts with 20+ years of experience in both large and start-up companies. Upon successful completion receive your course certificate that can be added to your LinkedIn education profile. Don’t see what you are looking for? Let us develop and deliver a customized course that fits your corporate needs, timing constraints, and budget!

Learn more about our current course offerings by clicking below

Live, Online Master Courses

View our current live course offerings here.

Medical Device Development Primer - one-day course

Medical Device Development Primer is a fast-paced, one-day preparatory course designed for professionals seeking a basic understanding of the industry. This course examines all aspects of medical device development, including the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course delves into the changing regulatory environment and focuses on the different pathways that devices travel for agency approval. Take this course to develop an understanding of the entire process required to bring a new medical device to market.

Medical Device Development Immersion - two-day course

Medical Device Development Immersion is a two-day course that surveys all aspects of medical device development. Learn about the changing regulatory environment and compare the FDA’s and European Union’s approval processes. Discover in detail the five phases of medical device development: market opportunity, evaluation, design, verification, and manufacturing. Take this course to develop an understanding of the entire process required to bring a new medical device to market.

Molecular Diagnostics Development - one-day course

Molecular Diagnostics Development is a one-day exploration of diagnostics’ journey from development to reimbursement geared for newcomers to the medical device industry. Understand concepts such as sensitivity, specificity, false positives, false negatives, and ROC curves. Learn how the FDA evaluates diagnostics and the various pathways to approval. The course ends with a look at how diagnostics are reimbursed on the market.

The Science of Molecular Diagnostics - one-day course

The Science of Molecular Diagnostics is a one-day course on the growing role of molecular diagnostics in health care. Learn how disease-causing mutations occur and about the diagnostics that identify how and where disease occurs. If your science background needs strengthening or you’re new to the business, this course will have you up and running in no time.

On-Demand Master Course Recordings

Medical Device Development Immersion - 8-hour course

Medical Device Development Immersion is an interactive, eight-hour preparatory course designed for those who need to better understand all aspects of medical device development. Beginning with an overview of the medical device industry, the course quickly delves into the changing regulatory environment and the different regulatory pathways devices can undertake for FDA or EMA marketing approval. Attention is then focused on a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing. The course ends with a brief look at commercialization, including reimbursement strategies. Learn from an industry expert with 30-years of experience in both large and start-up med device companies.

On-Demand, Online Classes

Diagnostics’ Role in Medicine Today - 41-minute online 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.

Medical Device Development - 57-minute online course

Medical Device Development provides a detailed look at the five stages of medical device development including market opportunity evaluation, concept evaluation, engineering design, verification/validation and manufacturing transfer. If you are an engineer, manufacturer, information technologist, investor or someone who finds themselves in development, Medical Device Development will broaden your knowledge of the entire development process.

Medical Device Overview and Regulation - 57-MINUTE ONLINE COURSE

Medical Device Overview and Regulation explores the diversity of the medical device industry by highlighting its various sectors, top companies and major regulatory bodies worldwide. Device classification and each classification’s differing approval pathways are outlined in detail. The course concludes with a look at the quality system regulations and risk management plans you must follow. If you are new to medical device, Medical Device Overview and Regulation will provide an understanding of the industry’s regulatory breadth.

SUGGESTED PREREQUISITES: DIAGNOSTICS’ ROLE IN MEDICINE TODAY

Medical Device Approval and Commercialization - 55-MINUTE ONLINE COURSE

Medical Device Approval and Commercialization explains the medical device approval process from initial regulatory submission through commercialization. Learn the diverse best practices accompanying a successful regulatory outcome, including manufacture scale-up, reimbursement strategy, product launch and post-launch assessment. If you are working in the diagnostics industry, this course gives you a game plan to undertake a successful launch.

SUGGESTED PREREQUISITES: MEDICAL DEVICE OVERVIEW AND REGULATION, MEDICAL DEVICE DEVELOPMENT

On-Demand, Online Classes (continued)

Diagnostic Development and Approval - 50-MINUTE ONLINE COURSE

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.

SUGGESTED PREREQUISITE: DIAGNOSTICS’ ROLE IN MEDICINE TODAY

How Diagnostics Work: DNA-Based Diagnostics - 44-MINUTE ONLINE COURSE

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.

SUGGESTED PREREQUISITES: THE BIOLOGY OF BIOTECH, DIAGNOSTICS’ ROLE IN MEDICINE TODAY, STATISTICAL FEATURES OF DIAGNOSTICS

How Diagnostics Work: Protein-Based Diagnostics - 40-MINUTE ONLINE COURSE

How Diagnostics Work: Protein-Based Diagnostics focuses on antibodies: what they are, where they come from and how they work. Various antibody-based diagnostics, such as sandwich and bead immunoassays, multiplexed assays, lateral flow assays and chromatography are explained in detail. Develop an understanding of these diverse tools and how to interpret results, knowledge that can be applied in research, drug development, and patient care.

SUGGESTED PREREQUISITES: THE BIOLOGY OF BIOTECH, DIAGNOSTICS’ ROLE IN MEDICINE TODAY, STATISTICAL FEATURES OF DIAGNOSTICS, AND ANTIBODIES

Statistical Features of Diagnostics - 47-MINUTE ONLINE COURSE

Statistical Features of Diagnostics surveys the measurements used to assess a diagnostic’s accuracy. Diagnostics must achieve a certain level of accuracy before receiving regulatory approval. Learn the meaning of variability, sensitivity and specificity and how each is calculated. Learn how these measurements are used to determine false negative and false positive percentages. If you are new to diagnostic development and need a primer on the measurements needed to achieve regulatory approval this course is for you.

SUGGESTED PREREQUISITES: DIAGNOSTIC DEVELOPMENT AND APPROVAL, DNA-BASED DIAGNOSTICS, PROTEIN-BASED DIAGNOSTICS