Medical Devices brochure - UCSC Extension Silicon Valley

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Medical Devices Certificate Prerequisites There are no prerequisites to enter this program. Medical Device Certificate Requirements Total: 17 units Required: 5 courses Elective: 6 units GPA: 3.0, and a C or better in all courses Timeline: Complete all required units within 3 years Note: Courses completed more than five years prior to date of certificate issuance cannot be used to fulfill requirements. Recommended Course Sequence For those with experience in this field, courses can be taken in any order. Those new to the field should start by taking “Introduction to Medical Device Regulation” and “Medical Device Quality Systems.” After that, core courses can be taken in any order, with the exception of “Human Factors and Usability in Medical Device Development,” which should be taken after the “Medical Device Quality Systems” and “Risk Management for Regulated Industries” courses. “Regulation of Medical Devices and Diagnostics” or “Medical Devices: Regulatory Strategies and Marketing Pathways” taken within the last 5 years at UCSC Extension fulfills the requirement of “Introduction to Medical Device Regulation.” If counted toward another certificate already, an additional 1.5 units of electives need to be taken. Benefits of Declaring Candidacy We encourage you to establish candidacy in a certificate program early in your studies. There are substantial benefits in doing so: • Curriculum changes subsequent to the date your application is received will not affect your course requirements. • Candidates will be notified of updates or special opportunities related to the program • Priority enrollment in fully enrolled courses. Curriculum Required Courses (five) Units Course Introduction to Medical Device Regulation...1.5.......30058 Medical Device Quality Systems..................2.5.......30087 Design Control for Product Development....2.0.......21973 Risk Management for Regulated Industries....................................3.0.......22631 Human Factors and Usability in Medical Device Development..................2.0.......23097 Elective Courses (6 units required) Units Course Mobile Medical Applications.......................0.5.......30045 Medical Device Verification and Validation...1.5.......30042 Product Development Life Cycle for Medical Devices.....................2.0.......23084 Post-Market Regulatory Obligations for Medical Devices.....................................1.5.......22414 Electronic Records for Regulated Environments: Cost-Effective Approaches to Compliance..........................1.5.......19362 Data Privacy and Security for Healthcare and Biosciences.........................1.5.......30120 Medical Device Marketing ..........................3.0.......30119 Value-Added Quality Audits.........................1.5.......19073 Note: Any one course from UCSC Extension’s Regulatory Affairs Certificate Program may be applied toward the elective unit requirement for the Medical Devices Certificate. Enrollment Information Visit ucsc-extension.edu/biosciences for the most up-to-date information about all our bioscience courses and programs, including instructor biographies, schedules and textbook requirements. Enroll online at ucsc-extension.edu. Required Courses Introduction to Medical Device Regulation Medical devices are defined broadly, including products ranging from multimillion-dollar linear accelerators to 99-cent boxes of alcohol wipes. This course provides an overview of how the design, manufacture and sale of these products are regulated in the U.S. The insights presented are essential for anyone working in the medical devices and diagnostics field. Discussions illustrate how cross-functional teams are essential to the success of pre-marketing submissions. Topics include the FDA and the medical device regulatory framework, agency law, the device classification system, routes to market, pre-market submissions, post-market requirements, interaction with the FDA, and the requirements for human studies. Also covered are current initiatives and trends, including how device regulations are evolving globally. Course 30058 Medical Device Quality Systems Lectures, interactive discussions and case studies provide in-depth exposure to the fundamental concepts and major issues central to the regulatory compliance in the medical device sector. Emphasis is on 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. Students learn about key quality system regulation processes and how to recognize noncompliance. The instructor provides insight into implementing an effective CAPA system and using it as an improvement tool. Current industry trends, FDA initiatives and best practices for interacting with regulatory agencies are also discussed. Course 30087 Copyright © 2012 The Regents of the University of California. All rights reserved.
Clinical Trials, Regulatory Affairs, and Medical Devices Program Overview Join us for a FREE program overview to learn about exciting new career opportunities in clinical research, regulatory affairs, and the medical device market. Ask instructors and program staff how you can apply our curriculum to your current job or to future endeavors. This quarterly event is a great introduction to opportunities you can discover through UCSC Extension Silicon Valley. Course 16650 For information and to register, visit ucsc-extension.edu/events. FREE EVENT Elective Courses 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. Students 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. Practical implementation of the design history file, reviews and records, transfer planning, configuration management, requirements engineering and project planning are highlighted. Course 21973 Risk Management for Regulated Industries This course provides an in-depth look at risk management with a focus on how it is applied to the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Lectures and interactive workshop sessions delve into the major risk management concepts and tools, including hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), mitigation application, regulatory requirements, and the creation of risk management reports and files. By the end of the course, students will be able to conduct competent and complete risk management for a variety for products, processes and services within the biomedical industries and beyond. Course 22631 Human Factors and Usability in Medical Device Development Understanding and applying human factors is essential to ensuring product usability and user satisfaction. Consideration of human factors also 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. Lessons address the integration of human factors and usability into the product development life cycle, regulatory considerations including applicable FDA guidance and standards (ANSI/IEC and human factors methods). The course will benefit professionals who already have a basic understanding of risk management and quality systems as well as those with no prior medical device experience. Course 23097 Data Privacy and Security for Healthcare and Biosciences Many healthcare and bioscience companies utilize Protected Health Information (PHI) or Personally Identifiable Information (PII) in order 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. Topics include relevant state, national and international data privacy and security regulations, medical device security and privacy, FTC requirements, HIPAA training and risk analysis requirements, among others. Not only will you understand issues relevant to your industry, but you will address these concerns by developing a plan of action toward compliance with relevant regulations and requirements. Course 30120 Medical Device Marketing This course discusses how to market medical devices in a regulated environment. You will learn to decode FDA promotional compliance requirements, develop the claims needed for promotion during the product development process, and understand how marketing can help develop and commercialize medical devices. The course reviews case studies and shares best industry practices in an effort to see how new digital media affects promotion choices, basic approaches to international marketing, and medical device distribution. By the end of the course, you will understand how to develop successful marketing campaigns to grow, share, or energize an aging brand, as well as to launch novel therapies. Course 30119 Mobile Medical Applications A growing number of health-related software applications are being developed for use on mobile platforms, including smart phones and tablet computers. This course will benefit professionals from the medical device sector involved with mobile medical app development and deployment. The course begins with an examination of the mobile platforms and existing mobile medical applications. It goes on to cover current FDA requirements for mobile medical applications and regulatory approaches to ensure the development of compliant, safe, effective and profitable apps. Course 30045 Medical Device Verification and Validation Proper verification and validation ensures that a medical device and its manufacturing process meet its design input requirements and conform to defined user needs and intended uses. Lack of or inadequate verification and validation is one of the most common reasons noted by ISO auditors and the FDA in the issuance of warning letters. After a review of the relevant regulatory terminology, participants learn how to implement a robust and cost-effective medical device verification and validation program. Topics include site validation master plan requirements; the validation of computer systems, facilities, utilities, laboratory instrumentation and manufacturing processes; how to write effective verification and validation plans, protocols and final results reports. This course will benefit professionals from crossfunctional teams in the medical device sector. Course 30042 Product Development Life Cycle for Medical Devices This course explores the phases, development processes, and deliverables essential to developing a medical device from concept to production scale up. Using a framework of gated stages and design review, the instructor details the timing and deliverables for each phase of device development. Process inputs and outputs are explained to provide an integrated view of the development team’s activities throughout the entire product lifecycle. In addition, the course highlights benefits and practical considerations related to concurrent development activity. The essential risk management and regulatory clearance aspects of the development process are also addressed. Course 23084 Courses continue on reverse…
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Medical Devices brochure - UCSC Extension Silicon Valley

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