Medical Devices

bioscience
yo u r U C i n S i l i c o n Va l l e y
Medical Devices
UCSC Silicon Valley Extension is offers 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.
ucsc-extension.edu/
meddevices
Medical Devices Certificate
Curriculum
Required Courses (five)
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 “Medical Device Quality Systems” followed
by “Introduction to Medical Device Regulation.” 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.
Required Courses
UnitsCourse
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)
UnitsCourse
Biomedical Ethics......................................... 2.5.......30246
Data Privacy and Security for
Healthcare and Biosciences......................... 1.5.......30120
Global Medical Device
Submissions and Strategy............................ 1.5.......20343
Medical Device Marketing .......................... 3.0.......30119
Medical Device Verification and Validation... 1.5.......30042
Mobile Medical Applications....................... 0.5.......30045
Post-Market Regulatory Obligations
for Medical Devices..................................... 1.5.......22414
Product Development
Life Cycle for Medical Devices..................... 2.0.......23084
Value-Added Quality Audits......................... 1.5.......19073
Validating Software for Medical Devices
and Emerging Technologies......................... 2.0.......30379
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.
Courses may be taken individually or
as part of the certificate program.
How are medical devices regulated, and what is
their path to market? This interactive course provides
a historical and regulatory overview of medical devices,
including definitions and types, classification systems,
routes to market, regulatory pathways, successful
investigational device exemption (IDE) and 510(k)/
PMA submissions to the FDA. You’ll learn how to get
devices to market most effectively, how to manage
and report adverse device events (MDRs) and other
post-market surveillance tools employed by FDA—
and get a glimpse into how device regulations are
evolving globally.
Course 30058
Medical Device Quality Systems
This 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 regulatory
environment. You’ll learn about key processes in the
quality system medical device regulation (21 CFR 820
and ISO 13485), while addressing noncompliance
challenges. The course covers implementation
of an effective CAPA system and using it as an
improvement tool, as well as industry trends, FDA
initiatives and best practices for interacting with
regulatory agencies.
Course 30087
Design Control for Medical Devices
Applying for a Certificate
We encourage you to establish candidacy
in a certificate program early in your studies.
This ensures that curriculum changes subsequent to
receipt of your application will not affect your course
requirements. Candidates will be notified of updates
or special opportunities related to their program.
Certificate applications can be submitted online
at ucsc-extension.edu.
Introduction to
Medical Device Regulation
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.
Copyright © 2015 The Regents of the University of California. All rights reserved.
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 insight into
the engineering value of design control throughout
the product lifecycle as it pertains to product quality.
You’ll learn the nine design control elements needed
to clarify design objectives, test products, and satisfy
customer requirements, thereby shortening the
path to product and business success. The course
highlights the practical implementation of the design
history file, reviews and records, transfer planning,
configuration management, requirements
engineering and project planning.
Course 21973
Are you interested in learning about the Clinical Trials, Regulatory Affairs, and Medical Device certificate programs, and about careers in these fields?
ophy, course content and program requirements, and gain insights into careers in clinical research, regulatory affairs, and medical devices.
Course 16650
To learn more, visit ucsc-extension.edu/events.
Session
This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philos-
Info
Clinical Trials, Regulatory Affairs, and Medical Devices Info Session
Elective Courses
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
analysis, fault tree analysis, failure modes and
effects analysis (FMEA), Hazard Analysis and Critical
Control Point (HACCP), mitigation application,
regulatory requirements, and the creation of risk
management reports and files. By the end of the
course, you’ll be able to conduct risk management
for a variety of products, processes and services
within the biomedical industries and beyond.
Biomedical Ethics
Medical Device Marketing
This course provides needed biomedical ethics
education for healthcare providers in all areas.
Course content is divided into four main sections:
(1) moral reasoning: ethical theory, professional
ethics, and ethics in physician-patient relationships;
(2) life beginnings: reproductive technology,
pre-implantation genetic diagnosis, and abortion;
(3) life’s quality: human subject research, healthcare
rights and rationing; enhancement ethics; and
(4) life endings: organ transplants, end-of-life
treatment refusals, and death with dignity. By the
end of the course, you will be able to think critically
about relationships between science and medicine,
biotechnology, and society.
This course discusses how to market medical devices
in a regulated environment. You’ll learn to decode
FDA promotional compliance requirements, develop
claims needed for promotion during the product
development process, and understand how marketing
can commercialize medical devices. The course reviews
case studies and shares best industry practices to see
how new digital media affects promotion choices,
approaches to international marketing, and medical
device distribution. By the end of the course, you’ll
understand how to develop successful marketing
campaigns to grow, share, or energize an aging
brand, as well as to launch novel therapies.
Course 30246
Course 22631
Human Factors and Usability
in Medical Device Development
Data Privacy and Security
for Healthcare and Biosciences
Course 30119
Medical Device Verification
and Validation
Understanding and applying human factors is
essential to ensuring product usability and user
satisfaction. This course introduces the fundamental
principles of human factors, covers core concepts and
demonstrates how human factors fit into medical
device software and hardware development.
Lessons address the integration of human factors
and usability into the product development lifecycle,
regulatory considerations, including applicable FDA
guidance and standards (ANSI/IEC), and human
factors methods. The course benefits professionals
familiar with risk management and quality systems,
as well technical professionals with no prior
medical device experience.
Many healthcare and bioscience companies utilize
Protected Health Information (PHI) or Personally
Identifiable Information (PII) to develop products or
perform 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. You’ll
examine issues relevant to your industry and address
these concerns by developing a plan of action
toward compliance with relevant regulations
and requirements.
Proper verification and validation ensures that
a medical device and its manufacturing process
meet its design input requirements and conform to
user needs and uses. This course reviews regulatory
terminology and discusses how to implement a costeffective 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; process validation requirements stated in ISO 13485 and FDA regulations;
writing effective verification and validation plans,
protocols and final results reports. The course
benefits professionals from cross-functional
teams in the medical device sector.
Course 23097
Course 30120
Course 30042
Global Medical Device
Submissions and Strategy
Mobile Medical Applications
The international nature of the medical device industry
presents opportunities and challenges for medical
device companies and regulatory affairs professionals.
Through interactive lectures and facilitated group projects, you’ll gain insight into the international medical
device requirements and regulations for global markets,
specifically in the EU, Canada, Japan, and China. This
course compares regulatory and process similarities
and differences between countries and underscores
their impact on global regulatory and business strategies. The course benefits regulatory affairs professionals
interested in helping their organizations understand the
barriers to entry into the global medical device market.
Course 20343
A growing number of health-related software
applications are being developed for use on mobile
platforms, including smartphones and tablet computers. This course will benefit professionals from the
medical device sector who are involved in mobile
medical app development and deployment. The
course examines the mobile platforms and existing
mobile medical applications and covers current FDA
requirements for mobile medical applications and
regulatory approaches to ensure the development
of compliant, safe, effective and profitable apps.
Course 30045
Courses continue on reverse…
Product Development Life Cycle
for Medical Devices
Validating Software for Medical Devices
and Emerging Technologies
This course explores the phases, development
processes, and deliverables needed to develop a
medical device from concept to production scale up.
The instructor uses a framework of gated stages and
design review to detail the timing and deliverables
for each device development phase. The course
explains process inputs and outputs to provide an
integrated view of the development team’s activities
throughout the product lifecycle. You’ll also learn
about the benefits and practical considerations
related to concurrent development activity, as well
as risk management and regulatory clearance
aspects of the development process.
Because an increasing number of medical devices
today run on software, there is a high demand for
quality assurance and regulatory affairs professionals
who can address the validation, documentation,
compliance and submission requirements unique
to software-controlled devices. This course covers the
software validation requirements of Class III medical
device software, mobile medical apps, medical device
data systems, manufacturing software, automated
test software, processes software, quality system
software and spreadsheets. Discussions cover the
FDA, EU and global perspectives on medical device
software validation and its related regulations,
guidance documents, and standards.
Course 23084
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 covers post-market regulatory
obligations and offers practical insight into efficient
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. The course discusses other
reporting and record keeping requirements for
industry trade organizations and the Office
of the Inspector General.
Explore UCSC Extension’s
Bioscience Programs
Bioinformatics
Biotechnology
Clinical Trials Design and Development
Regulatory Affairs
See ucsc-extension.edu/biosciences
for more information.
Course 30379
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 fundamental auditing principles and techniques, including planning,
conducting, analyzing, and communicating audit
results in terms that are meaningful to senior
managers. Through understanding the psychology
of audits and practice in questioning techniques,
you’ll learn to take your organization’s quality
audit program to another level.
Course 19073
Course 22414
Earn Two Certificates:
Learn More for Less
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 [email protected]
or call (408) 861-3860 if you need more
information or would like assistance
creating a study plan.
Not printed or mailed at state expense.
611791-1503-2093 (5/15/15)