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Re: New Folks - Please Take a Minute and Introduce Yourself/Say Hello!
Hi my name is Niki Skelly.
My job is Quality & Regulatory Manager.
I work for a Medical Device Manufacturer, we make dental caries detection devices.
The company is CarieScan Ltd, in Scotland, UK.
I have worked here for the last 2½ years.
We have been trading in the UK for some time now but are preparing to submit a 510(k) so I'm hoping to get some advice here, this process is all new to me.
My pet peeve is that everyone assumes Quality is just the Quality Managers responsibility, it's not, it's everyone's responsibility!
Regards
Niki
Hi my name is Niki Skelly.
My job is Quality & Regulatory Manager.
I work for a Medical Device Manufacturer, we make dental caries detection devices.
The company is CarieScan Ltd, in Scotland, UK.
I have worked here for the last 2½ years.
We have been trading in the UK for some time now but are preparing to submit a 510(k) so I'm hoping to get some advice here, this process is all new to me.
My pet peeve is that everyone assumes Quality is just the Quality Managers responsibility, it's not, it's everyone's responsibility!
Regards

Niki

to ISO 9001 and 13485. (I must have bored the auditor out of cognition....)