Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Can verification units undergoing non-destructive testing (tested by 3rd party vendor for safety and performance certification) be re-qualified to use as production units if records of design controls could demonstrate that the units were produced according to their approved assembly work instructions and that all materials/components were traceable?

Theoretically that would be possible as long as the design transfer has occurred.  And preferably the design transfer occurred prior to those units being manufactured as well.  A complete DHR should be compiled including manufacturing information, inspections, and testing that are to occur for the device.  It gets a little messy doing something like that, so you want to make sure your documentation is all clear - depending on the cost of the unit, might be better just to keep them for retain samples or similar for testing; then just make new products according to DMR.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 31-Aug-2018 15:39
From: Anonymous Member
Subject: Verification Units for Production

This message was posted by a user wishing to remain anonymous

Can verification units undergoing non-destructive testing (tested by 3rd party vendor for safety and performance certification) be re-qualified to use as production units if records of design controls could demonstrate that the units were produced according to their approved assembly work instructions and that all materials/components were traceable?

This message was posted by a user wishing to remain anonymous

Hi Richard,

So this is assuming that you could couple the design transfer with the creation of these verification units. That a DHR will be compiled, but there will be no sampling plans, as all received parts would have to be 100% inspected prior to incorporating into the device. 

Original Message:
Sent: 01-Sep-2018 02:31
From: Richard Vincins
Subject: Verification Units for Production

Theoretically that would be possible as long as the design transfer has occurred.  And preferably the design transfer occurred prior to those units being manufactured as well.  A complete DHR should be compiled including manufacturing information, inspections, and testing that are to occur for the device.  It gets a little messy doing something like that, so you want to make sure your documentation is all clear - depending on the cost of the unit, might be better just to keep them for retain samples or similar for testing; then just make new products according to DMR.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 31-Aug-2018 15:39
From: Anonymous Member
Subject: Verification Units for Production

This message was posted by a user wishing to remain anonymous

Can verification units undergoing non-destructive testing (tested by 3rd party vendor for safety and performance certification) be re-qualified to use as production units if records of design controls could demonstrate that the units were produced according to their approved assembly work instructions and that all materials/components were traceable?

I could not really answer your response without more detailed information, but that might be possible.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 04-Sep-2018 09:50
From: Anonymous Member
Subject: Verification Units for Production

This message was posted by a user wishing to remain anonymous

Hi Richard,

So this is assuming that you could couple the design transfer with the creation of these verification units. That a DHR will be compiled, but there will be no sampling plans, as all received parts would have to be 100% inspected prior to incorporating into the device.

Original Message:
Sent: 01-Sep-2018 02:31
From: Richard Vincins
Subject: Verification Units for Production

Theoretically that would be possible as long as the design transfer has occurred.  And preferably the design transfer occurred prior to those units being manufactured as well.  A complete DHR should be compiled including manufacturing information, inspections, and testing that are to occur for the device.  It gets a little messy doing something like that, so you want to make sure your documentation is all clear - depending on the cost of the unit, might be better just to keep them for retain samples or similar for testing; then just make new products according to DMR.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 31-Aug-2018 15:39
From: Anonymous Member
Subject: Verification Units for Production

This message was posted by a user wishing to remain anonymous

Can verification units undergoing non-destructive testing (tested by 3rd party vendor for safety and performance certification) be re-qualified to use as production units if records of design controls could demonstrate that the units were produced according to their approved assembly work instructions and that all materials/components were traceable?