B
The European Directive on medical devices utilizing animal tissues. This Directive covers devices incorporating animal tissues into the finished device but also has requirements concerning animal tissues (or derivatives) used during the manufacture of devices.
The ISO 13485/2003 auditor that we have in now is asking us how we intend to address the use of animal tissues as process aids, e.g. bovine stearates in polymers.
I am looking for any ideas of how others have addresses this and how they have handled it with their suppliers. Just getting into this, so not too sure on the direction to go. Has anyone else experienced this, and have their ISO auditors brought this up? I understand this is starting to become more and more of a hot topic.
Any help would greatly be appreciated.

The ISO 13485/2003 auditor that we have in now is asking us how we intend to address the use of animal tissues as process aids, e.g. bovine stearates in polymers.
I am looking for any ideas of how others have addresses this and how they have handled it with their suppliers. Just getting into this, so not too sure on the direction to go. Has anyone else experienced this, and have their ISO auditors brought this up? I understand this is starting to become more and more of a hot topic.
Any help would greatly be appreciated.
