Our medical device is in the last phase of design and development.
We are a start up medical device company in ***.
1. What stage of completion do we have to be in to be ready for an MDSAP audit?
2. Does our device need to be a finished device?
3. Does our DMR need to be completed and do we have to have all our verification and validation plans and reports completed?
Please let me know your thoughts on this.