Medical Devices brochure - UCSC Extension Silicon Valley

BIOSCIENCES
Medical
Devices
KNOWLEDGE YOU PUT TO WORK
COURSES AND CERTIFICATE
Who Should Attend This Program
Program Summary
UCSC Extension Silicon Valley
is now offering a unique certificate
in Medical Devices that covers topics
that are critical to the development
and commercialization of safe and
effective medical devices and in-vitro
diagnostics (IVDs). Experienced and
aspiring medical device professionals
can learn about medical device
product design and development,
regulatory and quality issues, innovation
strategy, risk management
and more. Extension courses offer an
exciting entry into a market estimated
at approximately $100 billion.
Not only is the medical device
industry lucrative—it produces
innovations that benefit people
in dramatic ways.
Program Contact
Applied and Natural Sciences Department
(408) 861-3860
extensionprogram@ucsc.edu
Join us for a FREE
Program Overview
to learn more.
Details inside…
ucsc-extension.edu/meddevices
• Medical device professionals of all levels of experience and those who want to enter this
expanding field
• Cross-development teams from medical device and IVD (in-vitro diagnostics) companies,
including those in Quality Assurance (QA), Regulatory, R&D, Product Development,
Software and Hardware Engineering, Product Management, Customer Support, Product
Verification and Validation, Marketing, Operations/Manufacturing and Clinical Research

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…

Post-Market Regulatory Obligations
for Medical Devices
After receiving regulatory approval or clearance
within the United States, a medical device is subject
to continuing regulation in the form of record keeping
and reporting to federal agencies, including the FDA.
This course provides a detailed overview of postmarket
regulatory obligations and offers practical
insights for efficient and robust systems that can
be implemented prior to market release. Discussion
topics include complaint handling, adverse event
reporting, device tracking, import/export requirements,
and the conduct of mandatory and voluntary recalls.
Other reporting and record keeping requirements for
industry trade organizations and the Office of the
Inspector General will also be discussed.
Course 22414
Electronic Records for
Regulated Environments:
Cost-Effective Approaches to Compliance
This interactive two-day course explores proven
techniques for reducing costs associated with implementing,
using, and maintaining computer systems
in regulated environments. The instructor addresses
the latest industry standards for data security, data
transfer, and audit trails. Students see how the FDA
regulation pertaining to use of electronic records
and signatures (21 CFR Part 11) and the HIPAA
electronic security regulations for medical records
fit into the validation process. Finally, the instructor
reviews recent FDA inspection trends and discusses
how to streamline SOP production.
This course benefits regulatory, clinical, and IT
professionals working in the health care, clinical
trial, biopharmaceutical, and medical device sectors.
Course 19362
Value-Added Quality Audits
By auditing to domestic and international quality
system regulations, biomedical corporations can
improve the effectiveness of their internal systems
and those of their suppliers and corporate partners.
This hands-on course introduces participants to
fundamental auditing principles and techniques,
including planning, conducting, analyzing, and com
municating audit results in terms that are meaningful
to senior managers. Through understanding the
psychology of audits and practicing questioning
techniques, participants can take their organization’s
quality audit program to another level.
Earn Two Certificates:
Learn More for Less
Course 19073
Students pursuing the
Medical Devices plus
Regulatory Affairs, Biotechnology
or Clinical Trials Design and Management
certificates need a minimum of 31 units,
including all required courses and elective units
for both programs. Please note that in order
to complete two certificate programs with
the minimum number of units, students must
select some electives that are common to both
programs. Contact us at extensionprogram@
ucsc.edu or call (408) 861-3860 if you need
more information or would like assistance
creating a study plan.
Explore UCSC Extension’s
Other Bioscience Programs
Bioinformatics
Biotechnology
Clinical Trials Design and Development
Regulatory Affairs
See ucsc-extension.edu/biosciences
for more information.
All courses held in
Santa Clara or Online
Near the Great America and
Bowers Avenue exit off Highway 101
Not printed or mailed at state expense.
611791-1204-1333 (09/3/12)