SMP 'Meet the Experts' Forum on Implantable Medical Device Reliability March 3, 2011

The Forum will include strategies for blood compatibility and design factors required for achieving biocompatibility of implantable devices.

The presentations will also include design approaches for using risk-based testing techniques for the transfer to manufacturing in terms of outside supplier quality, FDA, manufacturing process control and preventive product support. The program will include an interactive panel discussion. In panel will include Lee Carmack, Jack Coulter, Mike Silverman and Tom Roberts.

Lee Carmack will present design information on the Biologic and Hemodynamic Compatibility of Implantable Medical Devices. His talk will include the basics of device compatibility with the flowing blood and how the biological complexity of the flowing blood makes it one of the most demanding challenges of device design for internal environments.

Mike Silverman (OPS A La Carte) will explain the basic steps an implantable manufacturer must follow in developing a new medical product, as well as strategies for the efficient evaluation of risk-based testing for reliability and human safety. The presentation will include case histories and testing recommendations.

Jack Coulter will explain the specification and manufacturing requirements for an implantable medical device. His talk will include the transfer from engineering into manufacturing, qualification, process control, preventive action procedures and outside supplier quality.

A complimentary luncheon will be served to all attendees after the panel discussion.

Official Website: http://www.smptech.com/MTX_Medical-10303.htm