N
nyadav
Hello All
I am very new to this forum so please bare with me...
Right now, we are in the stage of preparing the documents for SDLC (Software Development Life Cycle) for a software which is itself a medical device and also used in medical device like MRI, CT scan machines.
Currently we are using Waterfall model for Software development. and we are planning to switch from Waterfall to Agile methodology,
we have following queries regarding usage of Agile methodology for SDLC of of medical device software.
1. Is Agile methodology compliance with FDA and CE requirements?
2. If we follow agile methodology then, what standard do we follow/refer?
3. If we follow agile methodology then, what type of documents we need to prepare in SDLC and what shall be the content of this document?
4.Difference between Agile and Waterfall model?
Thank you
I am very new to this forum so please bare with me...
Right now, we are in the stage of preparing the documents for SDLC (Software Development Life Cycle) for a software which is itself a medical device and also used in medical device like MRI, CT scan machines.
Currently we are using Waterfall model for Software development. and we are planning to switch from Waterfall to Agile methodology,
we have following queries regarding usage of Agile methodology for SDLC of of medical device software.
1. Is Agile methodology compliance with FDA and CE requirements?
2. If we follow agile methodology then, what standard do we follow/refer?
3. If we follow agile methodology then, what type of documents we need to prepare in SDLC and what shall be the content of this document?
4.Difference between Agile and Waterfall model?
Thank you