2-day In-person Seminar on Global Medical Device Regulation 2014

This course provides an overview of international medical device regulations. Beginning with a discussion of the similarity of global requirements, including both voluntary and mandatory standards and directives, and progressing to in-depth analyses of market specific requirements, the course provides the student with resources to meet the regulatory requirements for the largest world markets. Country-specific regulatory requirements for Canada, EU, and US are included.

Why should you attend?
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 regulatory intelligence, and selection of development and product approval pathways.

Areas Covered in the Session:
• 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