Nightjar wrote:
On 12/02/2012 23:48, Steve Firth wrote:
wrote:

On 12/02/2012 00:10, Steve Firth wrote:
...
Ah, it's Mr "Expert on Medical Devices", have you worked out that the PIP
board were covering up during inspection of their premises yet? After you
loudly declared that no such inspection was necessary the CEO admitted to
hiding the filler and the records during each inspection that you claimed
never happened....

I gave up on that thread when it became obvious that you were not
reading anything I wrote and were, instead, replying to a dialogue that
only you could hear. Despite what you have convinced yourself of, at no
time did I claim that a Class III medical device could have a CE mark
attached without an inspection.

snort

Yeh, lie to yourself before you lie to others, that's a great way to
cover up your fauxs pas. Not.

I have no need to lie. The claim exists only in your mind. I stated that
the only thing you need to place a medical device on the market in the EU
is a CE Mark on the product or its packaging. That is correct, but you
wrongly decided that meant it could be self-certified, which is something
I did not say and that I tried to get you to understand it did not mean.
There is little point in continuing this once more, as it is obvious that
you are incapable of accepting you made an error.

Had that been what you meant, one wonders why you stated dogmatically that
there is no requirement for the appointed body to inspect the manufacturer
(there is) and why you became terribly confused about inspection of the QA
system and inspection of the manufacturing records (the records falsified
by PIP that you claimed would not be inspected and that you claimed were
not required.

Whatever, you are clearly rewriting history in your head. Whereas in truth
you revealed that you know a little about class 1 devices and nothing about
class 2/2b/3 devices.