Lifecycle-driven scalable quality systems
6 - 9 months
12404756
This Program is Perfect For
- Early-career quality and regulatory professionals entering the medical device industry.
- Experienced quality, compliance, or regulatory professionals transitioning from other regulated industries.
- Quality, QA/QC, and Regulatory Affairs professionals seeking deeper knowledge of the Quality Management System Regulation (QMSR), ISO 13485, and the EU MDR.
- Internal auditors and compliance professionals building medical device–specific audit expertise.
Build expertise in global medical device regulations
The medical device regulatory landscape is undergoing significant transformation with the FDA’s implementation of the Quality Management System Regulation (QMSR), global alignment to ISO 13485, and strengthened European oversight under the EU MDR. Professionals must be prepared to interpret requirements, implement effective systems, and ensure audit readiness in a globally regulated environment.
This specialization delivers practical, hands-on expertise in three integrated areas: QMSR and ISO 13485 interpretation, EU MDR compliance strategy, and risk-based, process driven quality systems audits.
Why global regulatory compliance skills matter
Regulatory compliance is critical to bringing safe and effective medical devices to market. As regulatory frameworks evolve, organizations need professionals who can:
- Translate complex regulatory requirements into operational quality systems
- Prepare organizations for global regulatory inspections and audits
- Ensure documentation, clinical evaluation, and post-market surveillance meet international standards
Professionals with expertise in QMSR, ISO 13485, and EU MDR compliance are increasingly in demand across medical device manufacturers, biotechnology firms, and regulatory consulting organizations.
What you will learn
After completing the Global Regulatory Compliance specialization students should be able to:
- Interpret and apply requirements of the Quality Management System Regulation (QMSR) and ISO 13485:2016
- Develop an EU MDR compliance strategy for documenting clinical evaluations, technical documentation, and post-market surveillance
- Plan, conduct, and document risk-based, process-driven quality systems audits
Courses
Program Requirements
Total: 3 courses (7 quarter units)
End with Certificate of Completion review.
1. Required Course(s):
Currently no classes scheduled. Would you like to be notified when a class is available?
Currently no classes scheduled. Would you like to be notified when a class is available?
MEDD.X412
$750
You may enroll in this offering at any time.
Jul. 9 - Aug. 6, Thu, 6:00pm - 9:00pm
- Live-Online Attend via Zoom at scheduled times.
MEDD.X412.(2)
Schedule
| Date | Start Time | End Time | Meeting Type | Location |
|---|---|---|---|---|
| Thu, 07-09-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-16-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-23-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 07-30-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
| Thu, 08-06-2026 | 6:00pm | 9:00pm | Live-Online | REMOTE |
This class is offered in an online synchronous format. Students are expected to log into this course via Canvas at the start time of scheduled meetings and participate via Zoom, for the duration of each scheduled class meeting.
To see all meeting dates, click "Full Schedule" below.
You will be granted access in Canvas to your course site and course materials approximately 24 hours prior to the published start date of the course.
|| Prerequisites:
Prerequisites / Skills Needed
Summer
2. Completion Review:
O-CE0535
$50
You may enroll in this offering at any time.
Schedule
Please enroll in the Global Regulatory Compliance Completion Fee only when all of the specialization requirements have been met and your final grades are posted.
Recommended course sequence
Students new to the industry should begin with Quality Management Systems for Medical Devices: ISO 13485 and FDA QMSR.
For those with experience in this field, courses can be taken in any order provided the prerequisites are met.
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.
Establish Candidacy
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.
See Grading and Credits Policy for further information.
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