Helepolis
Mechanical
- Dec 13, 2015
- 201
Hi all,
We are developing a medical drug-delivery-device and nearing the clinical trials phase.
We have compiled all the relevant standard and regulations for a clinical device as a whole (a finished commercial product), but struggling to identify which regulations are mandatory for the non-commercial clinical trials phase and which ones can be "left for later".
We did come across a mention or two about some sources that help with exactly that, but unfortunately we couldn't find them.
If anybody came across such a source or have a suggestion(s) (from experience), it will be greatly appreciated.
Best,
SD
We are developing a medical drug-delivery-device and nearing the clinical trials phase.
We have compiled all the relevant standard and regulations for a clinical device as a whole (a finished commercial product), but struggling to identify which regulations are mandatory for the non-commercial clinical trials phase and which ones can be "left for later".
We did come across a mention or two about some sources that help with exactly that, but unfortunately we couldn't find them.
If anybody came across such a source or have a suggestion(s) (from experience), it will be greatly appreciated.
Best,
SD