"Dear All,
We just produce the sample of medical device for Customer from US (we are from Vietnam). Our company plan to certify FDA in next year. However, when Customer audit us, they ask to have DHR procedure inplace, we are almost unclear about it, Can anyone help to share the format or template of it
Must appreciated .. "
The DHR, and all of it's components, tells how the device was made to the specifications of the DMR. The DMR, and all of it's components, tells how the device was manufactured to the specificatons of the DHF. The DHF tells of the steps taken to design the device.
You should be aware that your device needs to be listed and registered with the FDA before you market your device in the USA. You do not need to "certify" your device with the FDA unless it is class III or a required class II device which need a 510(k) PMA approval.
Hope this helps...
