Brazil - The B in BRIC: Medical Device Requirements, Challenges and Lessons Learned
St. Cloud State Series
Registration: 7:30 am - 8:00 am
Program: 8:00 am - 9:30 am
This program is part of a series produced in conjunction with St. Cloud State University's Twin Cities Graduate Center, home to applied Master of Science degree programs for the med-tech industry.
Many medical device companies are interested in the Brazilian market to expand their business. As regulations increase and countries like Brazil implement new requirements, companies struggle to understand how to obtain the proper product approvals and maintain compliance. This presentation will cover basic information on Brazil's current regulatory framework for medical devices, discuss some of the challenges the industry faces today in placing products on the Brazil market, and share some best practices in order to succeed in this future growth country.
•Overview of Brazil medical device market
• Regulatory framework in Brazil for medical devices
• Medical device classification
•Quality system requirements
•Brazil's current international activity on medical devices regulations
• Things to consider to assure success
Scott S. Sardeson, RAC-EU/US, International Regulatory Affairs Manager, 3M
Scott S. Sardeson, RAC-EU/US He has held various positions at start-up and multinational medical device companies in manufacturing, research and development, quality, (more)
The following topics will be addressed:
St. Cloud State University
Twin Cities Graduate Center
6401 Sycamore Court N.
Maple Grove, MN 55369