DoC Webinar Medical Device Regulations
Date: June 5th, 2014Time: 2:00 EDT
Presented by: Wireless Research Center of North Carolina in conjunction with the U.S. Department of Commerce
If your company is planning to introduce a new wireless medical device to the market, don’t forget to design for the whole world – not just the U.S.
The global marker for wireless medical devices has never been hotter. A 2013 report, from the research conducted by Research and Markets (http://www.researchandmarkets.com), projects the market will expand more than 20 percent within a five-year period. The wireless health market, currently at $23.8 billion, is expected to reach $59.7 billion by 2018, with the growth attributed primarily to patient monitoring applications, diagnostics, aging populations and growing hospital deficits.
Join the U.S. Commercial Service and Dr. Gerard Hayes, President and CEO of the Wireless Research Center of North Carolina, for a webinar designed to help U.S. medical device companies understand the regulations required for entering foreign markets.
Bridging the gaps between telecom, defense and medical devices
• Fitness devices, Pacemakers, On-body & In-body Sensors
Overcoming Medical Device Challenges
• Understanding “Intended Use”
• Range of operation, battery life, performance optimization
Global Regulatory Approval Considerations
• US: FCC & FDA
• EU: European Telecommunications Standards Institute (ETSI)
• Japan: Ministry of Internal Affairs and Communications (MIC)
• Canada: Industry Canada (IC)
• Israel: Ministry of Communications (MoC)
• Korea: Korean Certification (KC)
Resources for technical guidance in multiple markets