510k submissions are an integral part of entering the USA 医療機器 market, and help you establish the safety and efficiency of your medical device.
While targeting the US market, a medical device manufacturing company must receive approval from the FDA stating that the applicant company can market the product in the US.
In this whitepaper, Kolabtree takes a look at the general FDA 510k submission process, how you can optimize your approach, and things to keep an eye on post-submission.
FDA（米国食品医薬品局）の基準に精通していないと 510(k)申請 process, it can really be stressful and challenging to break into the USA medical device market. This whitepaper intends to act as a guide, establishing the process and guidelines involved from start to finish.
Download the full whitepaper for free below.