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.
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.