Human Factors and Usability in Medical Device Development


Understanding and applying human factors is essential to ensuring product usability and user satisfaction. More importantly, consideration of human factors during the design and development of medical devices helps to ensure patient safety by minimizing the risks introduced by user error. This course begins with the fundamental principles of human factors and builds on that foundation each week to cover core concepts and demonstrate how human factors fit into the larger context of medical device software and hardware development.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X401.(2) 9/29/2018 09:00 AM SANTA CLARA 775 Kevin Michael Ten Brink View Enroll

Data Privacy and Security for Healthcare and Biosciences


Many companies in the healthcare and bioscience industries utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) to develop and test products such as medical devices and mobile applications, or to perform other services, including data analysis, on their customer’s healthcare related data. This course examines the important data privacy and security issues that govern these industries.

Prerequisites:


No prerequisites


Regulation of Medical Devices and Diagnostics


What's the origin story of a medical device? Medical devices encompass a broad array of products, ranging from the tongue depressor to surgically implanted stents and pacemakers. This course provides individuals from all backgrounds with a solid grounding in the laws, regulations and institutions that underlie the process of medical device and diagnostic product development and marketing.


The instructor first defines medical devices, provides an overview of the medical device industry and the historical roots of medical device regulation.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
REGL.X404.(2) 7/10/2018 06:00 PM SANTA CLARA 825 Clarisa A Tate View Enroll

Design Control for Medical Devices


The successful development of medical devices requires that the design be controlled to ensure product safety and that the device can fulfill its intended use. This course provides a practical understanding of the engineering value of design control throughout the product lifecycle as it pertains to product quality. You'll learn to use the nine elements of design control to make design objectives clearer, products more testable, and to better satisfy customer requirements, thereby shortening the path to product and business success.

Prerequisites:


Offering code Offering title
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X400.(2) 7/7/2018 10:00 AM SANTA CLARA 800 Farhan Shahab View Enroll

Quality Systems for Medical Devices: FDA QSR and ISO 13485


Through a series of lectures, interactive discussions and case studies, this course provides in-depth exposure to the fundamental concepts and major issues central to regulatory compliance in the medical device sector. The course emphasizes using the principles of the medical device quality system (QS) regulations and ISO 13485 as tools to take a process-oriented, risk-based approach to compliance, while achieving strategic business objectives in today's dynamic regulatory environment.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X407.(3) 9/25/2018 06:15 PM SANTA CLARA 800 Kiran Gulati View Enroll

Risk Management for Regulated Industries


This course discusses how risk management is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and workshops delve into risk management concepts and tools, including hazard identification, hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), Hazard Analysis and Critical Control Point (HACCP), mitigation application, regulatory requirements, the creation of risk management plans, reports and files, how to conduct Risk Management Reviews, and what might be audited in your Risk Management System.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X409.(2) 9/17/2018 06:00 PM SANTA CLARA 825 Barrett C. Craner View Enroll

Medical Device Marketing


Are you interested in making the leap from regulatory zero to marketing hero? The key to building a successful medical device business is finding balance between meeting regulatory requirements and maximizing marketing opportunities. It is critical that life science professionals understand the role of regulatory affairs and its impact on revenue generation. This course uses case studies (e.g.

Prerequisites:


No prerequisites


Medical Device Verification and Validation


Verification and validation is the process of determining whether a medical device and its manufacturing process meets design input requirements and ensures that devices conform to defined user needs and intended uses. It answers the questions, "Are you building the right safe and effective device?" and "Are you building it right?"


One of the most common reasons that ISO auditors and the FDA issue warning letters is because they notice an inadequate verification and validation—or a complete lack thereof.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X403.(1) 7/23/2018 06:00 PM SANTA CLARA 750 Bharat (Bill) C Kurani View Enroll

Mobile Health: The Evolving Industry and Regulatory Landscape


This interactive course provides a landscape of the evolving mobile health technology sector with an explanation of the equally dynamic framework created by U.S. regulatory authorities that oversee this transforming area. Emerging mobile health needs are met with the development of technological solutions enabling new models of delivery of care services and information. The new technologies span the entire lifecycle of care from wellness to chronic disease management and end-of-life care.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics
MEDD.X407 Quality Systems for Medical Devices: FDA QSR and ISO 13485
MEDD.X400 Design Control for Medical Devices

Mobile Medical Applications


A growing number of health-related software applications are being developed for use on mobile platforms, including smartphones and tablet computers. These applications are creating new and innovative ways for technology to improve health and health care. Consumers are using mobile medical applications to manage their own health and wellness and health care professionals are using applications to improve and facilitate patient care.




Developers of mobile medical apps and other medical devices professionals may be unsure about how or if FDA regulations apply to their products.

Prerequisites:


No prerequisites


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