Course

Global Medical Device Submissions and Strategy


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 EU, Canada, Japan, China and Brazil. 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 global medical device market.

Prerequisite(s):


Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Location Cost Instructor
04-04-2020 to 04-18-2020 1.5 CLASSROOM $750

Patrick Lee

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Schedule

Date: Start Time: End Time: Meeting Type: Location:
Sat, 04-04-2020 8:30 a.m. 5:00 p.m. Classroom with Online Materials SANTA CLARA
Sat, 04-11-2020 8:30 a.m. 12:30 p.m. Classroom with Online Materials SANTA CLARA
Sat, 04-18-2020 8:30 a.m. 12:30 p.m. Classroom with Online Materials SANTA CLARA

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