Medical Device and Diagnostic Courses

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 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 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.

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 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.