Chandler Loop System ®
How to start. Basic reflexions in advance.
The fundamental problem of those who have to check haemocompatibility for regulatory purposes is, that all efforts are centered towards the aim to find nothing. No effect. Everything is ok, when nothing happens.
It's not easy, to distinguish wrong testing (nothing happens) from successful tests of good materials (nothing happens). Overdosed anticoagulation of the blood samples or not fresh enough blood: If the blood is already dead, nothing happens...
Best practise:
Nothing compares to first hand experience with the subject. The way to success leads over bloody hands. Who begins in a small way, parallel to the product development process, will turn out to be expert while fullfilling regulatory duties in the end.
