Hi,
If my ocmpany shift medical device (Class II) production from one country to another country do I need to perform design verification. There is no change to suppliers, design, equipments only the site change. Is there any FDA requirement that design verification is a must.

Thank You

Desmond

…as long as your performing design, you need to perform design verification regardless of no changes in suppliers, design or equipments changed…

FDA Chapter I - Food & Drug Adminsitration
Subchapter H - Medical Devices
Part 820 Quality System Regulation
Title 21, Volume 8
Revised as of April 1, 2007

Sec. 820.30 Design Controls
...(a) General. (1) Each manufacturer of any Class III or Class II Device, and the Class I Devices shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.

...(f) Design Verification. Each manufacturer shall establish and maintain procedures for verifying the device design. Design verification shall confirm that the design output meets the design input requirements. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, shall be documented in the DHF.

Hi Chnggp

I don't believe you do if you are changing production site only.

However to meet CE regulations you must inform your Notified Body as this would be considered a substantial change to your QMS and product certification.Your technical file will also need to be updated.

Your 510(k) will also need to be updated and sent to FDA by your authorised representative in USA.

You had better complete a full process validation as well prior to full production at your new site. This will give you added assurance to your process in your new plant.

Finally expect an audit of the new site.

Hope this helps.

Hi,
If my ocmpany shift medical device (Class II) production from one country to another country do I need to perform design verification. There is no change to suppliers, design, equipments only the site change. Is there any FDA requirement that design verification is a must.

Thank You

Desmond

If you are using same suppliers, design, equipment (and processes?) then other things you might want to consider are environment does the new site have different environmental conditions? will this have an effect of the device?

How is the installation being managed? I would think you need to show that after install the device meets required specs... would this not be a verification/validation/qualification that designed requirements for the device are being met.

This is not a case of do design inputs meet meet design outputs but a case of are designed requirements being met at this different manufacturing site.