H
Hrobot
Dear all,
Our software development SOP (for a class 2 medical device with an embedded software) is based on EN 62304. I am now trying to submit a 510(k) and realised that the terminology for software testing requirement has changed from Unit Testing and verification/System testing to IQ/OQ/PQ (Installation/Operational/Performance Qualification).
Do we have to change our terminology documentation format to fulfill FDA's requirement?
The same goes to the final device functionality test protocol. Whilst this is fine for MDD do I need to create an IQ/OQ/PQ protocol for the US market?
Your advice will be greatly appreciated
H
Our software development SOP (for a class 2 medical device with an embedded software) is based on EN 62304. I am now trying to submit a 510(k) and realised that the terminology for software testing requirement has changed from Unit Testing and verification/System testing to IQ/OQ/PQ (Installation/Operational/Performance Qualification).
Do we have to change our terminology documentation format to fulfill FDA's requirement?
The same goes to the final device functionality test protocol. Whilst this is fine for MDD do I need to create an IQ/OQ/PQ protocol for the US market?
Your advice will be greatly appreciated
H
Last edited by a moderator: