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ISO 13485. Is it worth to the Medical Device Industry.

Posted 29th May 2015 at 09:33 AM by somashekar

While the ISO 13485 is the medical devices QMS - requirements for regulatory purposes., where are the CBs about regulatory purposes. Is it not the domain of the CB with competency built in its auditors to audit and report the applicable regulatory compliance...
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Good things coming back to you ...

Posted 30th December 2012 at 01:16 AM by somashekar
Updated 30th December 2012 at 10:47 AM by somashekar

Dec 27th 2012:
The whole of day was with no power supply due to some maintenance works in our locality, and by evening the electric supply was restored. All was fine for a while and my system was put on. The power was on for a while and then to...
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