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.
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
1. What stage of completion do we have to be in to be ready for an MDSAP audit?
You have to be completely ready for the audit from both sides: ISO 13485:2016 and Technical file according to the MDR.
2. Does our device need to be a finished device?
Yes, your device must 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?
Yes, your all verification and validation plans and reports must be completed.
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Oct 21, 2020