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Regulatory & Quality Solutions , LLC

3919 William Penn Highway - Suite 200

Murrysville, Pennsylvania 15668

United States

Company Description

RQS team members pride ourselves on focusing on customer success, and it is with that in mind that I am honored to announce our most recent 510(K) submission was approved this week! We are proud to obtain clearance, but swell with pride because of how we ... more

Find other employees at this company (67)

Background Information

Employment History




Blue Tree Angel

CV SBU Regulatory Director

Medrad , Inc.





Mechanical Engineering


Mechanical Engineering

University of Pittsburgh

Web References (20 Total References)

R&Q's Blog | medical device [cached]

Set the Strategy - Maria Fagan, Regulatory and Quality Solutions Create the Design - Carolynn Johnson, Daedalus

Our President, Maria Fagan, ... [cached]

Our President, Maria Fagan, has written an article focused on the top five tips on how to successfully address FDA warning letters.

Maria Fagan, ... [cached]

Maria Fagan, President Maria Fagan ( has extensive experience in medical device development across regulatory and quality areas as well as post-surveillance and compliance. She uses her experience to provide strategic guidance and support to early stage development teams and start-up companies. Maria holds a B.S. in Mechanical Engineering and has worked in the medical device quality and regulatory arena.

Seton Hill : E-Magnify: Success Stories [cached]

Q&A with Co-founder of Regulatory & Quality Solutions - Maria Fagan

Seton Hill : E-Magnify: Success Stories [cached]

Q&A with Co-founder of Regulatory & Quality Solutions - Maria Fagan Seton Hill : E-Magnify: Success Stories

Q&A with Co-founder of Regulatory & Quality Solutions - Maria Fagan
(Back row, L-R: Kim Kramer and Beth Slagle, APL panel members; Front row, L-R: Maria Fagan, president & co-founder, and Robert Markley, vice president & co-founder, of RQS)
Maria Fagan is president and co-founder (along with Robert Markley and Lisa Casavant) of Regulatory & Quality Solutions, LLC, a business based in Murrysville, PA.
Maria worked with E-Magnify as part of its ATHENAPowerLink® mentoring program. Here she shares some thoughts on entrepreneurship and the experience of working with E-Magnify.
E-Magnify: Please tell us a little bit about Regulatory & Quality Solutions (RQS).
Maria Fagan:RQS provides services to medical device companies that enable their devices to be sold worldwide.

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