Visit our COVID update page.
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 OutcomesAt 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
- Submission elements
- Developing a strategy
- A outline for a strategy document
- 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 InformationPlease review section notes to view the full schedule.
Have a question about this course?
- Save Your Seat
Help us confirm course scheduling. Enroll at least seven days before your course starts.
- Accessing Canvas
Learn more about gaining access to your course on Canvas in our FAQ section.
Accessibility and Accommodation
For accessibility questions or to request an accommodation, please visit Access for Students with Disabilities or email the Extension registrar.
Finance Your Education
Here are ways to pay for your education.
This course is related to the following programs:
Sections Open for Enrollment:
|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|