Dear all,
I would like to ask you the following issue we are dealing with. Thank you very much in advance for all your support. Appreciate it!
The situation is the following: There is a company developing a new medical device which is being manufactured by a subcontractor in a certified facility. Several tests have been carried out with these devices in order to eventually submit the documentation to a Notified Body. But, before that happens, the subcontractor manufacturing the devices changes its manufacturing plant to a different location, although the manufacturing procedures are more or less the same. Shall the company re-do all the tests that were carried out with the devices from the old plant? What would the company need to demonstrate in order for those studies be considered acceptable by a Notified Body?
pd: Notified Body: the competent authority in charge of evaluating MD in Europe
J.
I would like to ask you the following issue we are dealing with. Thank you very much in advance for all your support. Appreciate it!
The situation is the following: There is a company developing a new medical device which is being manufactured by a subcontractor in a certified facility. Several tests have been carried out with these devices in order to eventually submit the documentation to a Notified Body. But, before that happens, the subcontractor manufacturing the devices changes its manufacturing plant to a different location, although the manufacturing procedures are more or less the same. Shall the company re-do all the tests that were carried out with the devices from the old plant? What would the company need to demonstrate in order for those studies be considered acceptable by a Notified Body?
pd: Notified Body: the competent authority in charge of evaluating MD in Europe
J.