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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, 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 the global medical device market.

Skills Needed


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

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

Notes


Have a question about this course?
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Call (408) 861-3860
FAQ
ENROLL EARLY!
This course is related to the following programs:

Prerequisite(s):

Sections Open for Enrollment:

Open Sections and Schedule
Start / End Date Units Cost Instructor
06-04-2022 to 06-18-2022 1.5 $750

Patrick Lee

Enroll

Schedule

Date: Start Time: End Time: Meeting Type: Location:
Sat, 06-04-2022 8:30 a.m. 5:00 p.m. Live-Online REMOTE
Sat, 06-11-2022 8:30 a.m. 12:00 p.m. Live-Online REMOTE
Sat, 06-18-2022 8:30 a.m. 12:00 p.m. Live-Online REMOTE