ISO 13485 Consultant Question - The company has 5 part time employees

#1
Good evening,

My company is based in Alabama and manufactures a class I medical device that already has 510(k) clearance and we are required to complete ISO 13485 certification in order to sell to one of our international customers.

The company has 5 part time employees; however, I am the only person who could provide resources/time toward the introduction of a QMS.

Can anyone here recommend the names of a few reputable companies that you have had good experiences with in the past for ISO 13485 consulting services? I assume we are going to have to start from scratch and I am trying to determine whether the certification will be too costly to pursue.

Thank you in advance for your help and let me know if there are any relevant details that I can provide that I didn't cover.
 
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#2
I have done the QMS/certifications for several small companies. I can give you some inputs if you can share with me your current 510k number so I can see if it is relevant to my industries.
 

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