Validating Software for Medical Devices and Emerging Technologies


With the increasing number of medical devices running on software, there is an enormous demand for quality assurance and regulatory affairs professionals who can address the validation, documentation, compliance and submission requirements unique to software-controlled devices.

Prerequisites:


Offering code Offering title
REGL.X404 Regulation of Medical Devices and Diagnostics
MEDD.X400 Design Control for Medical Devices

Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
MEDD.X410.(1) 1/22/2018 06:00 PM SANTA CLARA 800 Mary Beth McDonald View Enroll

Value-Added Quality Audits


In today's dynamic business environment, every aspect of an organization needs to perform value-added activities that have a positive impact on the bottom line. Regulatory and quality units in more and more biomedical industry corporations are relying on quality audits as a means to improve operations. By auditing to domestic and international quality system regulations (GXP, QSR and ISO), these organizations are assessing and improving the effectiveness of their internal systems and those of their suppliers and corporate partners.

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.X407.(1) 4/28/2018 08:30 AM SANTA CLARA 700 Kiran Gulati 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


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


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

Bioscience Program Information and Q&A Session


This free evening event is an informal discussion geared towards new or returning students interested in one or more of the Bioscience certificate programs -- Biotechnology, Bioinformatics, Clinical Trials Design and Management, Regulatory Affairs, and Medical Devices. The event begins with a short overview of the five Bioscience certificates, followed by an open-floor segment for audience questions.

Prerequisites:


No prerequisites


Clinical Trials, Regulatory Affairs, and Medical Device Information Session


Are you interested in learning about the Clinical Trials, Regulatory Affairs, and Medical Device certificate programs, and about careers in these fields?
This special information session provides an opportunity to meet instructors and other students, learn about program prerequisites, program philosophy, course content and program requirements, and gain insights into careers in clinical research, regulatory affairs, and medical devices.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
16650.(026) 1/9/2018 06:30 PM SANTA CLARA 0 View Enroll

Medical Devices Certificate Completion Review


Once all of the certificate requirements have been met and your final grades are posted, please access your Student Portal to enroll in the “Certificate Completion Review” to begin the review process. Please allow up to 4 weeks to receive your certificate.

Prerequisites:


No prerequisites


Sections :


Section Start Date Time Location Cost Instructor Name Full Schedule Enroll
O-CE0403.(006) // 04:00 PM 75 View Enroll
Medical Devices

Group

About

Devise a Better Future

How are medical devices tested, developed and marketed? From Band-Aids to insulin pumps, in vitro diagnostics to hearing aids, medical devices benefit the lives of people across the globe. If you’re looking for a career in a growing industry, skilled professionals are needed to research, develop, regulate, test, and market new devices and biologics. Our Medical Devices certificate offers the foundation you need in product design and development, regulatory and quality issues, innovation strategy, risk management and more.

Pick up skills course by course or declare candidacy for the certificate to add a UC credential to your resume.

Learn the Lingo

Regardless of your position in the medical device industry, it’s critical that you can speak to the latest FDA requirements and ethical considerations. Our courses can prepare you to do just that.

Calculate Risk Well

When testing and developing new products, stakes are high. Learn how to plan effectively in our courses.

Earn Two Certificates For Less

Complete two Bioscience certificates, simultaneously or in sequence, with fewer units, by selecting shared electives. Contact us to get help creating a personalized study plan.

The Profession

With the global wearable medical devices market poised to grow at an annual growth rate of more than 17 percent over the next decade—to reach about $23.8 billion by 2025—this is an excellent time to consider all the opportunities in the medical device industry. Scientific research is more sophisticated and rapidly changing all the time. The medical device industry needs a qualified workforce. Depending on your background, experience, and ambition, you can find fulfilling work in numerous areas:
•  Quality assurance (QA)
•  Regulatory affairs
•  Research and development
•  Product development
•  Software and hardware engineering
•  Product management
•  Customer support
•  Product verification and validation
•  Sales and marketing
•  Operations and manufacturing
•  Clinical research

SALARIES
$33,365–$119,515 - average annual pay for a medical device sales consultant in the U.S.. (Payscale)
$154,130 - average annual pay for a medical device sales consultant (2017 Medical Device Sales Salary report)

Outcomes

Program Objectives

As a graduate of the Medical Devices certificate program, you’ll have the skills to:

  • Use nine elements of design control for medical devices
  • Navigate post-market regulatory requirements for devices
  • Market medical devices
  • Decode regulatory compliance, including medical device quality system regulations and ISO 13485
  • Explore the product development life cycle for medical devices
  • Set up and implement medical device verification and validation programs

FACULTY

Program Chair

At UCSC Extension, courses are developed by program chairs and faculty according to the rigorous University of California standards and designed to meet the economic needs of each industry. Our instructors represent the best of both worlds.

KIRAN GULATI, RAB-LA, M.B.A., is a management consultant with more than 20 years of experience in quality systems and process improvement for the medical device and biotech sectors. She has taught for UCSC Extension since 2006. Ms. Gulati has held positions at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the auditing and quality system training functions. Ms. Gulati has extensive experience designing and presenting training for companies in domestic as well as international settings. Since 2001, she has helped a large number of medical device startups and established companies achieve successful results during ISO 13485, CE Mark assessments and FDA audits.  

Ms. Gulati serves on the advisory board for UCSC Extension’s Medical Devices and Regulatory Affairs Certificate programs. In addition, she has been a speaker at conferences sponsored by the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. Ms. Gulati served as the RAPS San Francisco/Bay Area Chair from 2011 to 2014 and is currently on the RAPS North American Advisory Board.

Curriculum

Program Format

UCSC Extension’s Medical Devices courses are offered at UC Santa Cruz Silicon Valley Campus, a beautiful facility located on the corner of Scott and Bowers in Santa Clara. Many of our courses are available online. Choose courses according to your interest or declare candidacy in the certificate for a more comprehensive overview of the field.

Medical Devices Courses

Required: 5 courses

Electives: 4.5 units required

To complete the certificate, you must complete 5 required courses and at least 4.5 units of elective courses.

Required Courses:

  • Design Control for Medical Devices, 2 units
  • Human Factors and Usability in Medical Device Development, 2 units
  • Regulation of Medical Devices and Diagnostics, 3 units
  • Quality Systems for Medical Devices FDA QSR and ISO 13485, 2.5 units
  • Risk Management for Regulated Industries, 3 units

Electives:

4.5 units required

  • Data Privacy and Security for Healthcare and Biosciences, 1.5 units
  • Global Medical Device Submissions and Strategy, 1.5 units
  • Medical Device Marketing, 3 units
  • Medical Device Verification and Validation, 3 units
  • Mobile Health: The Evolving Industry and Regulatory Landscape, 1 unit
  • Mobile Medical Applications, 0.5 unit
  • Post-Market Regulatory Obligations for Medical Devices, 1.5 units
  • Regulation of In Vitro Diagnostics in Europe and the US, 2.5 units
  • Validating Software for Medical Devices and Emerging Technologies, 2 units
  • Value-Added Quality Audits, 1.5 units

Prerequisites

There are no prerequisites for entering this program, although an understanding of statistics is necessary. “Statistics” is recommended for students entering the program without prior knowledge.

Recommended Course Sequence

Those new to the field should start by taking “Quality Systems for Medical Devices FDA QSR and ISO 13485” followed by “Regulation of Medical Devices and Diagnostics.”  After that, core courses can be taken in any order. For those with experience in this field, courses can be taken in any order.

“Introduction to Medical Devices Regulation” or “Medical Devices: Regulatory Strategies and Marketing Pathways” taken within the last 5 years at UCSC Extension fulfills the requirement of “Regulation of Medical Devices and Diagnostics.” If counted toward another certificate already, an additional 1.5 units of electives need to be taken.

Any one course from UCSC Extension's Clinical Trials Design and Management or Medical Devices Certificate Programs may be applied toward the elective unit requirement for the Regulatory Affairs Certificate.

INFO SESSIONS

Want to learn more about our curriculum in person? Join us for a free Info Session to learn more about our courses, faculty, and program requirements. Learn more on our Events page.

PRICE

The rough cost of the Medical Devices certificate is estimated at $7,000.

Enroll

Enrollment

No application is required to enroll in our courses or certificate programs. Information about our open enrollment process can be found on our Enrollment page. If you have any questions about our programs, please contact the UCSC Extension Outreach office by phone at 408-861-3860, or by email at extensionprogram@ucsc.edu.

From the schedule below, click on a course title to see sections available for enrollment. You may view the full course schedule, or enroll in the course, by clicking the respective button. The course type offerings (classroom, online, blended) are guidelines and subject to change. A blended (hybrid) course has both classroom and online components.

Declaring Candidacy

If you intend to pursue a certificate, declaring candidacy establishes program requirements early in your studies, so any subsequent curriculum changes do not affect your progress. It does not limit what courses you can take; and it helps you structure your professional development program for maximum benefit to you. Go the declare candidacy page to establish your requirements for this program. Certificate program requirements must be completed within three years of declaring candidacy.

Course Schedule


1. Required Courses
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
2. Elective Courses
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
3. Required Certificate Review
classroom : Classroom
online : Online
hybrid : Blended
Classroom and Blended : Classroom and Blended
Classroom and Online : Classroom and Online
Online and Blended : Online and Blended
Offering Code Offering Units Fall Winter Spring Summer
O-CE0403 Medical Devices Certificate Completion Review

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