Regulatory & Quality Solutions

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    R&Q has worked in every FDA medical device clinical specialty. We provide leadership and expertise for regulatory strategy domestically and internationally... and the execution to make it all happen. We specialize in verification and validation, human factors/usability, safety risk management, and design quality. With our help, create your very best device. Our services include supplier quality and audits, manufacturing site transfer, manufacturing quality, and process validation. 

    HQMonroeville, PA, US
    Employee Ratings4.6

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    Employees (est.) (Jun 2021)373(+6%)
    Cybersecurity ratingBMore

    Regulatory & Quality Solutions Office Locations

    Regulatory & Quality Solutions has an office in Monroeville
    Monroeville, PA, US (HQ)
    2790 Mosside Blvd #800
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    Regulatory & Quality Solutions Blogs

    [Webinar] Strategies for Overcoming the Biggest Challenges in Achieving IVDR Compliance

    The latest addition to our webinar series covers the biggest challenges in IVDR compliance. With hundreds of MDR submissions under our belts and a number of clients who have already received findings from their IVDR applications, we have learned a lot about the regulation, the guidance t…

    RQM+ Quick Guide to Medical Device Recall Management

    Medical device recalls are daunting in many ways—manufacturers dread them, competitors love them, and patients don’t always understand them. A medical device recall could be a response to patient safety concerns or to unanticipated negative trends. All manufacturers should assume it will…

    How to Prepare a Design History File for FDA Inspection

    Food and Drug Administration (FDA) inspections are stressful, especially if your documentation isn’t audit-ready. Creating and maintaining a compliant design history file (DHF) will help ensure that when the time comes, you’ll be ready for an FDA inspection that results in minimal findin…

    A Comparison of IVDR to FDA IVD Regulatory Submission Requirements

    The European Union’s new In Vitro Diagnostic Regulation (IVDR) May 2022 implementation date is fast approaching. If you sell IVDs in multiple markets, it may be challenging to determine the differences between the IVD regulations in the U.S., the existing IVDD, and the new IVDR. It’s not…

    The EU MDR Date of Application Has Arrived!

    The European Union (EU) Medical Device Regulation (MDR) 2017/745 date of application is here! To celebrate the incredible effort medical device manufacturers have put in so far to get to this point, we have compiled a brief review of the remaining EU MDR timeline and a list of brand new …
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    Regulatory & Quality Solutions Frequently Asked Questions

    • When was Regulatory & Quality Solutions founded?

      Regulatory & Quality Solutions was founded in 2008.

    • How many employees does Regulatory & Quality Solutions have?

      Regulatory & Quality Solutions has 373 employees.

    • Who are Regulatory & Quality Solutions competitors?

      Competitors of Regulatory & Quality Solutions include GAES, Qardio and Secure Care Products.

    • Where is Regulatory & Quality Solutions headquarters?

      Regulatory & Quality Solutions headquarters is located at 2790 Mosside Blvd #800, Monroeville.

    • Where are Regulatory & Quality Solutions offices?

      Regulatory & Quality Solutions has an office in Monroeville.

    • How many offices does Regulatory & Quality Solutions have?

      Regulatory & Quality Solutions has 1 office.