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Internal audit consultant ISO 13485 (English speaker)

#1
Hello,

I am QA/RA manager in a french start-up (first product in development) and we are ISO 13485 certified since early this year.
I am looking for a consultant with experience in auditing ISO 13485 QMS to perform an internal audit by the end of the year. We made our first internal audit with a french consultant but our external audits are performed in English and the certification audit was a hard exercise for me - my English tends to be very bad when I'm anxious and it was very frustrating!
We decided to do our next internal audits in English (native or fluent in English) so we will be better prepared for our next external audits.
Do you have any suggestion of experienced internal auditor in Europe (UK, Germany, Belgium, ...)? A consultant used to work with start-ups would be a plus!

Thank you very much!
Mhalik
 
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JoshuaFroud

Involved In Discussions
#2
Hi Mhalik,

I probably cannot help you myself, however, letting people know roughly where the audits would need to be conducted would be useful information? If you dont want to give a full address thats fine but a country or region would help people as distrance of travel may well be a key thing in selecting an consultant auditor.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
What kind of devices? Is the company a specification developer or do you also have manufacturing in-house?
 
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