Let Us Put Over 30 Years Seasoned Regulatory Experience to
Work for You
With the changing policies at FDA,
it takes a seasoned regulatory professional to understand all the
requirements and develop a meaningful and strategic plan to get your
products to market. European (EU) clearance has distinct challenges with the
new changes to the Medical Device Directive. As such, it takes an
experienced regulatory professional to guide your product through
the CE marking process.
REGSolutions, LLC provides strategic consulting for medical device
regulatory affairs, quality and clinical needs, including
registrations for market entry in the USA and European (EU), regulatory rescue,
quality system builds, and clinical registrations (IRB, IDE).
We can provide short-term or long-term assistance with:
clients include companies of all sizes, from international
corporations to local, independent startup firms.
30 years experience in strategic regulatory planning, quality
management systems, auditing and training, we have the know-how to
get your product to market and keep you in compliance with federal
and international regulations.
Let’s talk today about how REGSolutions can help you.