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


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


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


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X405.(1) 1/26/2018 09:00 AM SANTA CLARA 385 Bharat (Bill) C Kurani View Enroll

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.(1) 1/16/2018 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.(1) 2/3/2018 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.(2) 4/2/2018 06:15 PM SANTA CLARA 800 Kiran Gulati View Enroll

Post-Market Regulatory Obligations for Medical Devices


Once medical devices are on the market, manufacturers are required to follow specific requirements and regulations. This includes investigating complaints, submitting to the FDA's eMDR system for reporting device malfunctions, injuries or deaths; handling recalls, managing post-market surveillance studies requirements under section 522 of the Federal Food, Drug and Cosmetic Act, as well as post-approval studies required at the time of approval of a premarket approval (PMA); and handling advertising and promotional labeling.

Prerequisites:


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

Global Medical Device Submissions and Strategy


The global nature of the medical device industry presents both opportunities and challenges for medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the EU, Canada, Japan, China and Brazil.

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
REGL.X401.(2) 4/7/2018 08:30 AM SANTA CLARA 750 Patrick Lee 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

Regulation of in vitro Diagnostics in Europe and the US


This course offers a comprehensive overview of the current European and U.S. Regulatory and Quality Affairs for in vitro diagnostic (IVD) products. You will gain a perspective on the critical elements of the regulatory requirements for obtaining IVD marketing approval. This course will take an extensive look into specific in vitro diagnostics topics and learn about the new and emerging regulatory requirements surrounding them.

Prerequisites:


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

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