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.

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

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 Hours

RAC Points: 4

Medical Device Certificate Core Course

Enrollment Period: 12 months

Learning Objectives

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