Medical Device Quality and Design
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certificate Description
From tongue depressors to Fitbits
Digital health, smart wearable devices, medical device software and in-vitro diagnostics are just a few of the latest strides in the highly regulated healthcare industry.
In the Medical Device Quality and Design certificate program students focus on technological and regulatory advancements in the field. They learn the fundamentals and underlying concepts of regulatory compliance, as well as global harmonization quality compliance initiatives.
You'll study the front end of medical device design and development used to verify that design inputs meet design outputs, including:
- User needs,
- Risk management,
- Human factors, and
- Methodologies.
What you will learn
- Interpret and develop documentation that complies with:
- U.S. FDA quality system requirements (21 CFR 820)
- European Medical Device Regulations (EU MDRS / IVDRS), ISO 13485
- Risk management (ISO 14971)
- Write a risk management plan and risk management report
- Apply risk management principles to develop verification and validation plans for software and manufacturing processes
- Develop a human factors usability plan
- Interpret FDA guidelines and regulations and develop quality test plans for digital health and medical device software
- Explain and apply risk management principles defined in ISO 14971 throughout the design and development lifecycle, such as product risk, software risk, and cybersecurity risk
Program Overview
Estimated Cost: Starting at $4,875 (You pay only for courses you enroll in.) | International Tuition Cost
Program Requirements: 6–8 courses (14 quarter units)
Minimum Hours of Instruction: Minimum 140 hours of instruction.
Estimated Duration: A full-time student can complete the certificate in 9–12 months.
Special Programs:
Courses
1. Core Course(s): Medical Device Quality & Design - 14 Units
2. Completion Review:
Meet Our Instructors
Certificate Inquiry Form
Professional Development
RAPS credit
Prepare for certification. Earn credit toward recertification
Helps prepare professionals with three to five years in the regulatory field for the Regulatory Affairs Certification (RAC) exam, the only post-academic professional credential for regulatory professionals in the healthcare product sector.
Programs related to the scope of regulatory practice as defined by the RAPS competency model and/or the RAC content outlines that meet the RAC recertification requirements are eligible to earn RAC recertification credits. A full-day program may qualify for six credits per day. There is a 12-credit maximum for a multi-day event. For more information on how many points can be earned, see the RAC recertification guide.
Recommended Course Sequence
Please follow this sequence. Students new to the industry should begin with Quality Systems for Medical Devices FDA QSR and ISO 13485 (formerly Medical Device Quality Systems) followed by Regulation of Medical Devices and Diagnostics. For those with experience in this field, courses can be taken in any order provided the prerequisites are met.
Substitution
An introductory course to medical devices regulation or Medical Devices: Regulatory Strategies and Marketing Pathways taken within the last five years fulfills the requirement of Regulation of Medical Devices and Diagnostics.
Requisite Knowledge
Please review the course descriptions to ensure that you have taken necessary prerequisites or meet the requirements through job experience or previous education.
Statistics knowledge: You will need an understanding of statistics for this program. UCSC Extension offers Statistics.
Advisory Board
Certificate Program Chair
KIRAN GULATI, RAB-LA, M.B.A., is a management consultant with more than 25 years' experience in quality systems and process improvement for the medical device and biotech sectors. She has held positions at Genentech and McGhan Medical (formerly Collagen Corporation), where she managed the auditing and quality system training functions and has extensive experience designing and training for companies in domestic and international settings. Since 2001, she has helped medical device startups and established companies achieve successful results during ISO 13485, CE Mark assessments, and FDA audits. Gulati has served as chair of RAPS San Francisco Bay Area chapter and is currently on the RAPS North American Advisory Board. She has been a speaker at conferences sponsored by the Institute of Validation Technology (IVT) and the ASQ Silicon Valley Division. She has taught for UCSC Extension since 2006 and serves on the advisory boards for the UCSC Extension Medical Devices and Regulatory Affairs certificate programs.
Certificate Program Advisory Committee
MEREDITH BROWN-TUTTLE, BA, RAC, FRAPS
Regulatory Affairs Consultant
Regulatorium
Author, Instructor
KIRAN GULATI, RAB-LA, M.B.A.,
Principal Medical Device Consultant/Exemplar Medical Device Lead Auditor
Kiran Gulati & Associates
Program Chair, Regulatory Affairs, UCSC Silicon Valley Extension
Program Chair, Medical Devices, UCSC Silicon Valley Extension
NANCY E. ISAAC, JD, MPH
Regulatory Counsel and VP Quality
Moximed, Inc.
NIRANJAN MAHARAJH, MS, BS
Director, R&D
Carl Zeiss Meditec, Inc.
JENNIFER MASCIOLI-TUDOR, MBA, BS
Vice President, Quality Assurance & Regulatory Affairs
Outset Medical, Inc.
Establish Candidacy
Who should establish candidacy?
- People who are pursuing a certificate (and have enrolled in a course in the program).
- People who want to lock in the current requirements of a certificate or specialization.
4 Simple Steps to a Certificate or Specialization
- Complete a course in your selected program.
- Establish candidacy. Click on the Establish Candidacy button on your program page.
- Take all required courses for certificate completion.
- Once your grades are posted on your final course, enroll in the certificate review fee.
A Benefit of Establishing Candidacy
Program requirements may change. Once you commit to a program by establish your candidacy, you will not have to change your plans to meet new requirements. They are locked in for you. Timeline: 4 years to get it done (or 3 for a specialization) You must complete all the necessary units in a certificate within a four-year window. The clock begins on the first day of your first course in the certificate program. For example, if you started a course on Sept. 5, 2023, you would have to finish by Sept. 4, 2027.
Note: Establishing candidacy does not trigger the beginning of the four-year window. It begins the first day of the first course in your chosen certificate program. The Certificate Completion Review process does not have to occur within the four-year timeframe.
Exceptions to the four-year requirement
- If you Established candidacy prior to Jan. 1, 2024, you will have five years to complete a program.
- Students participating in a special program, such as workforce, international, or our curriculum partner programs, such as the Legal Studies courses (CLS by Barbri) and sales and business courses (Ziplines Education) have shorter completion requirements.
Grade Requirements
Please note that only letter grades of C or higher may be applied to a certificate, and in some programs, students may have more stringent requirements. Students in most employer- and government-sponsored payment programs, such as workforce development, as well as international students on F-1 visas, need to maintain a B average to meet their requirements. Personal Financial Planning students have additional grade requirements for individual courses to attain a certificate.
See Grading and Credits Policy for further information.