Is it possible to get iso 13485:2016 certified as a one man band


I have an idea for a series of products that would be classed in the EU as a class iia medical device.

In order to meet the QMS requirements it seems sensible to get 13485 certified.

Before I commit any real time, effort and money to this, I want to know if it is possible, as a one man band, to achieve this certification.

Any shared knowledge and help appreciated.

Ronen E

Problem Solver
Staff member
Super Moderator
Yes, theoretically it's possible.
If all you currently have is an idea, the QMS is not among the first things I would tackle though.

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