Internal audit consultant ISO 13485 Needed in France (English speaker)

[Mhalik]

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

 

[JoshuaFroud]

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.

 

[Mhalik]

Hey!
We are a french start-up, based in Paris

 

[Ronen E]

What kind of devices? Is the company a specification developer or do you also have manufacturing in-house?

 

[easmith]

Hi Mhalik,

I know this reply is far later than the time frame you intended to conduct your internal audits but I wanted to see if you found someone suitable to conduct the audits. As a certified quality auditor & lead auditor, I have conducted several ISO 13485 internal audits for start-up medical device companies and I am a native English speaker. If you're still looking, perhaps we can discuss in more detail to see if my experience a good fit for your needs and how I can help you.

Best regards,
Emily

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