Global Regulatory Strategy for Medical Devices

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.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Learning Activity
  • Registration Options

At A Glance

  • Target Audience: This course is intended for those who are interested in, or may be involved in, global regulatory strategy as it relates to medical devices, in-vitro diagnostics (IVDs) and related products.
  • Learning Level: Basic
  • Total Length of Course: 4–8 Hours
  • RAC Credits: 4
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $455; List $630
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Learning Objectives

Upon completion of this course, participants should be able to:

  • Describe the elements impacting the definition and classification of medical devices globally
  • Determine the points to consider in the development of a global regulatory strategy
  • Define the tools for global regulatory strategy development
  • Recognize sources of regulatory and competitive intelligence
  • Identify the elements of a regulatory plan
  • Apply global regulatory principles to develop a regulatory plan, including STED documents for global registrations

Lesson Titles

  • Lesson 1: Medical Device Rules in Different Regions
  • Lesson 2: Regulatory Strategy Elements
  • Lesson 3: Regulatory Documentation
  • Lesson 4: General Regulatory Strategy

Learning Activity

Learning Activity

This scenario-based activity lets you practice your regulatory decision-making in a safe and interesting way. Follow the events of a hypothetical story, gain important background information and hear stakeholder opinions before having to make choices about various regulatory issues. Then, see how those choices impact the story, company, product and characters. Complete this activity multiple times and see how things can change when you vary even one of your choices.

Registration Options

This course is available for purchase as follows: