Risk Management for Medical Devices-Nancy Madison-01/27/2009 - 8:30am

Event Information
Event Topic: 
Risk Management for Medical Devices
Event Date: 
01/27/2009 - 8:30am
Event Location: 
Sunnyvale
Speaker Information
Event Speaker: 
Nancy Madison
Event Speaker Title: 
President
Event Speaker Company: 
Compliance Express
Event Speaker Bio: 

Nancy Madison is President and founder of Compliance Express, a company which provides regulatory compliance products, services, and training for medical device companies. Prior to founding Compliance Express, Nancy was Chief Marketing Officer for Peak Process where she led the marketing, product specification, and application engineering development efforts for its quality management products. Prior to joining Peak Process, Nancy’s career spanned 22 years in the high tech industry in a variety of engineering, applications engineering, marketing, consulting, and management positions at both industry leaders such as Hewlett-Packard and Mentor Graphics and successful startups such as Legato Systems and Valid Logic Systems. Nancy received a B.A. from George Washington University, an M.A. from Harvard University, and an M.S.E.E. from the University of California, Berkeley.

Event Details
Cost: 
$0 - Free
Event Details: 

Risk management is an essential part of regulatory compliance for medical device companies. In spite of its ever increasing importance, it is not always easy to find the information needed to determine specific risk management requirements and how to fulfill those requirements throughout the entire product life cycle of a medical device. This presentation will focus on how to develop a risk management strategy which incorporates appropriate risk management activities at each stage of the product life cycle. Nancy will give an overview of US and Global risk management requirements, discuss the primary source documents to be consulted in developing a risk management strategy, and give practical advice on how to incorporate risk management activities into the critical phases of the product life cycle.