The quality and efficacy of a medical device does not end once it’s off the manufacturing line. Typically, the final devices are packed. Such packaging processes need to be validated. Additionally, as the packaged devices are not sterilized and immediately used at the location of the packaging process, both the transport impact and the storage upon the device and its packaging system have to be validated. Devices need to get into the hands of users intact and within time for them to be effective and safe for use. Packaging must protect the device during transportation and maintain its sterility if applicable.
This 1-hour webinar recording delivered live February 11, 2015 provides an overview of the testing and validation studies device manufacturers must use to demonstrate to regulators that the packaging does not compromise the effectiveness of the device at the time of use.
Speaker: Jan Peeters - Global Program Manager, Scientific Director & Primary Designated Engineer (PDE) – UL MDT
Please register to view the recorded webinar: