北京百力诺思医疗器械科技有限公司

December 1, 2016

Hosted by P&L Scientific Inc. Supported by Vera Rosas Group of Brazil.2nd International Medical Devices Regulations Forum was held in Shenzhen Convention and Exhibition Center during CMEF Shenzhen on October 30, 2016. 

The forum covers Brazilian ANVISA regulation and US FDA regulation. A large audience was attracted , from major European Notified Body, well-known medical equipment companies and in vitro diagnostic (IVD) companies, medical equipment industry associations. Brazilian regulatory experts, responded to questions raised by manufacturers, including the types of medical equipment sold in the Brazilian market, the registration requirements for specific products, the process of ANVISA GMP audits. And discussed the coordination of the MDSAP with the Brazilian regulation.

P&L Scientific FDA regulatory seminar describes how to establish a customer complaint handling system that complies with US FDA QSR inspection requirements and discussed with leading medical device manufacturers on the depth of device failure analysis, customer complaint handling processes, and FDA's latest QSR audit requirements.