Tuesday, 13 November 2018
BioPharmaceutical Technology Center
5445 East Cheryl Parkway
Fitchburg, WI 53711
+1 608 277 2669
For medical devices, risk management spans the entire product lifecycle, from development to deployment and decommissioning. It is an essential system to ensure expectations for product safety on the drawing board are realized in actual clinical use. More and more quality systems and product standards rely on risk management to set priorities and make decisions, out of less than complete information. Join others from your region to hear two interactive presentations on managing risk throughout the product lifecycle.
The first presentation will outline how closed-loop risk management can support consistent decision making for safety throughout the product lifecycle for any medical device. The second presentation will discuss risk management considerations specific to In Vitro Diagnostic (IVD) medical devices, such as how to consider harm for devices that do not directly contact patients. It will also explore risks in the context of how a device is used, which may require the device to work in combination with other reagents, instruments and/or software to provide a reliable result.
Don’t miss this unique opportunity to learn new and innovative ways to manage risks while connecting with others from your local regulatory community. This event, hosted at Promega Corporation, is coordinated by the RAPS Wisconsin chapter and is intended to encourage professional development and engagement among regulatory professionals in your areas. A meal will be available for all participants and RAC holders may claim three RAC recertification credits.
Featured speakers:
Daniel Biank, RAC, JD, MSE, PE, vice president, regulatory affairs, global EHS and radiation safety, Accuray
Carol Lindsay, RAC, PhD, senior scientist, Promega Corporation
Registration Information:
RAPS Member: $30.00
Nonmember: $45.00