A
AndMAC
Hi all,
I'm from a US based company which markets a device in both the US and EU. It is FDA approved and has the CE mark. We are currently performing clinical testing (IDE) in the US and we also have several registry studies we intend to begin. Does ISO 14155:2011 apply to non-interventional registry studies? Would there be consequences if our registry studies did not comply with ISO 14155:2011, which I know has been harmonized with the MDD?
Any advice or knowledge would be much appreciated!
Thanks!
I'm from a US based company which markets a device in both the US and EU. It is FDA approved and has the CE mark. We are currently performing clinical testing (IDE) in the US and we also have several registry studies we intend to begin. Does ISO 14155:2011 apply to non-interventional registry studies? Would there be consequences if our registry studies did not comply with ISO 14155:2011, which I know has been harmonized with the MDD?
Any advice or knowledge would be much appreciated!
Thanks!