Problem
You are developing a test for a plastic that comes into your facility. The plastic is made of a new polymer that is both conductive and preformed to fit over your new pacemaker with the fancy Bluetooth, Cloud Controlled app.
1) What tests would you conduct on the polymer prior to building your device?
a) What properties would you likely identity as important to the quality of the incoming plastic?
b) What would you be measuring?
c) How would you measure it?
d) How might you validate the tests?
2) What types of testing would you conduct on the plastic before conducting clinical trials? E.g. (are there ISO standards, Guidance Documents?)