510k Submission

You can’t afford for FDA compliance to be an afterthought.

The United States is one of the world’s largest markets for the healthcare industry due to its unique combination of population, capital, and overarching regulations. For medical device and software companies, adhering to FDA standards and regulations  is both complicated and absolutely necessary.  We have assisted multiple healthcare clients in the development and documentation of their solutions and have secured 510(k) clearance (previously known as premarket notification) for over a dozen solutions.

Skills

Identifying requirements for launching medical device software in the U.S. market

Analysis determining the best approach for securing FDA approval

A streamlined process for compilation of documentation

Support and guidance in reapproval process related to changes in the intended use

Are You Ready for a Solution?

This is a perfect opportunity to find the solution to your problems. Please feel free to request a free 30 minute consultation..

Are You Ready for a Solution?

This is a perfect opportunity to find the solution to your problems. Please feel free to request a free 30 minute consultation..
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Our Offices

Office In the US :

1039 Chrome Rd.
Oxford, PA 19363
Office In Hungary:

Vasvári Pál u. 1/C
H-9024 Győr
+36-96-550-521