Regulatory Submissions
Your Express Lane to the US Market.
From standard 510(k) to complex De Novo and Pre-Subs. Use the power of **eSTAR** combined with our expert strategy to secure clearance without the regulatory loop-de-loop.
The Challenge
Predicate Strategy
?뱀씤 ?깃났??90%瑜?醫뚯슦?섎뒗 '湲고뿀媛 ?쒗뭹(Predicate Device)' ?좎젙???꾨왂?곸쑝濡??섑뻾?섏뿬 ?낆쬆 遺?댁쓣 理쒖냼?뷀빀?덈떎.
Pre-Sub Meeting
FDA ?ъ궗愿怨??ъ쟾 誘명똿(Q-Sub)??二쇰룄?섏뿬, ?꾩긽 ?쒗뿕 ?꾨줈?좎퐳??????숈쓽瑜?誘몃━ 諛쏆븘?닿퀬 遺덊솗?ㅼ꽦???쒓굅?⑸땲??
RTA Zero
eSTAR ?묒꽦??湲곗닠???ㅻ쪟濡??명븳 '?묒닔 嫄곕?(Refuse to Accept)'瑜??먯쿇 李⑤떒?섎뒗 寃利??꾨줈?몄뒪瑜??댁쁺?⑸땲??
Frequently Asked Questions
De Novo???몄젣 ?꾩슂?쒓???
Required when no Predicate exists. We help you secure Class II classification instead of Class III PMA.
?꾩긽?쒗뿕???꾩닔?멸???
90% of 510(k)s don't need clinicals. Bench testing is usually sufficient.
?ㅻぐ 鍮꾩쫰?덉뒪 媛먮㈃ ?쒗깮? ?대뼸寃?諛쏅굹??
We handle the Small Business Qualification to reduce your user fees by up to 75%.