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Medical Device and Diagnostic Courses

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

Online and Onsite Courses 

All training is developed and delivered by industry experts with 20+ years of experience in both multinational 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 Master Courses

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 Medical Device industry. This course examines the 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 understand the 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 interactive course designed for those who need to understand the business and regulatory considerations of medical device development. The course highlights include the regulatory pathways for FDA or EMA marketing approval; the changing regulatory environment; a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing; and commercialization strategies, including those for reimbursement. Learn from an industry expert with 30 years of experience in both multinational and start-up medical device companies.

Molecular Diagnostics Development one-day course

Molecular Diagnostics Development is a one-day exploration of a diagnostics journey from development to reimbursement. Learn how the FDA evaluates diagnostics and the various pathways to approval. Understand sensitivity, specificity, false positives, false negatives, and ROC curves. The course ends with a look at reimbursement and its influence on the business of diagnostic development.

The Science of Molecular Diagnostics one-day course

The Science of Molecular Diagnostics is a fast-paced, one-day course on the growing role of molecular diagnostics in healthcare. Learn how disease-causing mutations occur and the diagnostics identifying how and where the disease manifests. If your science background needs strengthening or you’re new to the sector, this course will get you up to speed on the science driving molecular diagnostics.

Recorded Master Courses

Medical Device Development Immersion Eight-hour course

Medical Device Development Immersion is a two-day interactive course designed for those who need to understand the business and regulatory considerations of medical device development. The course highlights include the regulatory pathways for FDA or EMA marketing approval; the changing regulatory environment; a detailed explanation of the five development phases—market opportunity, evaluation, design, verification, and manufacturing; and commercialization strategies, including those for reimbursement. Learn from an industry expert with 30 years of experience in both multinational and start-up medical device companies.

On-Demand short Classes

Diagnostics’ Role in Medicine Today 41-minute online class

Diagnostics’ Role In Medicine Today introduces the ever-expanding molecular diagnostics industry. Diagnostics save lives by helping pinpoint the disease’s exact cause and location. Learn the purpose of each 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 healthcare, Diagnostics’ Role in Medicine Today will provide a solid foundation to build your diagnostic acumen.

Medical Device Development 57-minute online class

Medical Device Development provides a detailed look at the five stages of medical device development, including market opportunity evaluation, concept evaluation, engineering design, verification and validation, and manufacturing transfer. Understand the FDA guidances for process design, qualification, and monitoring. Learn how risk assessment, reimbursement, and the ability to scale-up manufacturing determine if a product development plan moves forward or not.

The Regulatory Process For Medical Device 57-minute online class

The Regulatory Process for Medical Device explains how medical devices are regulated in the United States. Medical device classification and each classification’s differing approval pathways are discussed in detail. FDA guidelines, quality system regulations, and risk management plans are also discussed in great detail. If you are new to the medical device industry, this class will provide an understanding of the breadth of the industry’s regulatory requirements.

 

Medical Device Approval and Commercialization 55-minute online class

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 medical device sector, this course gives you a game plan to undertake a successful launch.

Diagnostic Development, Approval and Reimbursement 41-MINUTE ONLINE CLASS

Diagnostic Development, Approval, and Reimbursement 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). The second section describes the regulatory requirements for Class I, II, and III diagnostic approval pathways. A review of the internationally recognized quality system regulations (QSR), focused on the design and manufacturing QSRs, closes out this section. Diagnostic Development, Approval, and Reimbursement ends by explaining Medicare, Medicaid, hospital, and private payer reimbursement in terms of inpatient DRG codes and outpatient CPT codes.

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

How Diagnostics Work: DNA-Based Diagnostics explains the role and uses of PCR, microarrays, gene sequencing, and microRNA technology as diagnostics. Learn the names of the machines and consumables, workflow, and how to interpret the results of each technology. Gain entry into the fast-paced field of DNA-based diagnostics by understanding the science driving a standard set of diagnostic tools.

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

How Diagnostics Work: Protein-Based Diagnostics focuses on antibodies: what they are, where they come from, and how they work. Various antibody-based diagnostics are explained in detail, including sandwich and bead immunoassays, multiplexed assays, lateral flow assays, and chromatography. Gain an understanding of these diverse protein-based diagnostics by learning the knowledge each brings to patient care and how to interpret their results.

Understanding Diagnostic Measurements 47-MINUTE ONLINE CLASS

Understanding Diagnostic Measurements surveys the measurements used to assess a diagnostic’s accuracy because a test must achieve a certain level of accuracy before receiving regulatory approval. Understand how these measurements determine false negative and false positive percentages. Learn the meaning of variability, sensitivity, and specificity and calculate each. This course is for those new to diagnostic development who need a primer on the necessary measures to achieve regulatory approval.