FRA: Global Regulatory Strategy for Medical Devices Course + FRA Exam

The medical device market changes frequently in terms of technology, risk potential, marketing and reimbursement. Therefore, it is imperative for regulatory professionals to be aware of existing requirements and new developments in the global market. As a participant you will learn how to ask the right questions and adapt the course concepts to your own organization.

This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development. It offers guidelines for developing successful global strategies for medical devices, including definitions and classifications worldwide, elements of regulatory strategy, sources of competitive and regulatory intelligence, selection of development and product approval pathways and suggestions for professional development.

This bundle also includes the Foundation in Regulatory Affairs (FRA) exams for both medical devices and pharmaceuticals. Passing the exams earns you the FRA credential and proves to current and future employers that you have mastered the content from these courses. Learn more about the FRA. 

Bundle includes:

Global Regulatory Strategy for Medical Devices
This course provides a basic description of global regulatory strategy for medical devices and explains the relationships between regulatory strategy and product development.

Passing this assessment shows you have gained important regulatory knowledge and will allow you to earn the FRA: Global Regulatory Strategy for Medical Devices Assessment-Based Certificate.
 

Access Period: You have 12 months to take the exam from the time of purchase.