ISO 13485 Certification for one-person startup




I developed a line of sensors, which can be used for medical applications. Now, I finalized the design and had a short production run. I went through FDA 510K and obtained clearance as Class II device (due to power requirements). I registered both device and my office with FDA.

I have the major components contracted to others, but still kept firmware programming at my rented office space. So, I registered as both spec developer and manufacturer with FDA. Even it is Class II in US, it is considered as Class I, non-sterile/non-measuring per EU MDD 93/42/EEC. When I consider international market, it seems ISO 13485 is a common standard, no matter what class my products belong to. My questions are:

  1. Can one-man company be certified to 13485? In another word, is there any provision to prevent me from obtaining cert due to process restrictions on how many DIFFERENT natural person are required for DIFFERENT roles to ensure quality? Can I declare all required roles on me?
  2. I can prepare all quality documents myself. How much does it cost to have someone to certify me? (review all documents, ask questions, and issue cert, etc.) I am based in Delaware.
Thanks in advance!:thanx::thanx:
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Yes a one man company can be certified to ISO 13485
You need someone to perform an internal audit.
Speak to several registrars that offer ISO 13485 certificates. Examples include BSI, SGS, TUV, KEMA,Intertek, etc... Ask if they have local auditors.


Thanks, Liuyy. This is not for CE marking. Some countries ask for ISO 13485 cert. regardless of device classifications. More like a business validation.


Hi, are you saying that design controls won't allow one nature person to fill all roles? I didn't read full context of the chapter.


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for one thing you can't review your own work; for example 820.30(e) states ...and an individual(s) who does not have direct responsibility for the design stage being reviewed.
You will also have hard time explaining to an FDA inspector how you eliminated bias when establishing the design inputs and performing verification and validation.

Also, keep in mind that getting FDA clearance is only small part of the whole story; you have to manage all other aspects of the quality system too e.g. supplier management, customer complaints and all the other fun stuff.


Quite Involved in Discussions
Sorry for a little bit off topic, I cannot get my head around ...
So, why were you registered and 510k-ed a sensor at FDA?
Many thanks
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