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Global Medical Device Submissions and Strategy | REGL.X401

Global Medical Device Submissions and Strategy | REGL.X401

The global nature of the medical device industry presents both opportunities and challenges for medical device companies and regulatory affairs professionals who must navigate a diverse regulatory terrain. Through interactive lectures and facilitated group projects, students gain a practical understanding of international medical device requirements and regulations for major and emerging markets around the world, with emphasis on the US, EU, Canada, Japan, and China. A comparative approach highlights regulatory and process similarities and differences between countries and underscores the impact they have on global regulatory and business strategies. This course will benefit regulatory affairs professionals who need to help their organizations understand the barriers to entry into the global medical device market.

Learning Outcomes

At the conclusion of the course, you should be able to
  • Describe what a medical device regulatory strategy is and its elements
  • Discuss the various regulatory submission types, their contents, and format
  • Explain why a strategy is important and how it drives the business
  • Identify common pitfalls of submissions and strategies

Topics Include

  • Submission elements
  • Developing a strategy
  • A outline for a strategy document

Necessary Knowledge

  • To be successful in this class all students should have working knowledge of Google Workspace or Microsoft Office, proper email etiquette, and an essential understanding of Canvas.

Additional Information

Please review section notes to view the full schedule.
Have a question about this course?
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Call (408) 861-3860
This course is related to the following programs:


Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Quarter Units Cost Instructor
04-08-2023 to 04-22-2023 1.5 $750

Patrick Lee


Final Date To Enroll: 04-08-2023


Date: Start Time: End Time: Meeting Type: Location:
Sat, 04-08-2023 8:30 a.m. 5:00 p.m. Live-Online REMOTE
Sat, 04-15-2023 8:30 a.m. 12:00 p.m. Live-Online REMOTE
Sat, 04-22-2023 8:30 a.m. 12:00 p.m. Live-Online REMOTE