Regulatory & Quality Solutions

    OverviewSuggest Edit

    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, US
    Employee Ratings4.5

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    Employees (est.) (May 2020)200(+2%)

    Regulatory & Quality Solutions Office Locations

    Regulatory & Quality Solutions has an office in Monroeville
    Monroeville, US (HQ)
    2790 Mosside Blvd #800
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    Regulatory & Quality Solutions Financials and Metrics

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    Regulatory & Quality Solutions Online and Social Media Presence

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    Regulatory & Quality Solutions Blogs

    R&Q's Remediation Station: Tools & Tips

    Welcome to the Remediation Station! We've got live shows with the experts, case studies, and insights to help you get through remediation successfully.  First up, join us Friday, May 8 11:00am ET / 8:00am PT for Device Love Live #4: Best Practices for Reducing Pain in a Medical Device R…

    DEVICE L❤️VE Live! #5 — 5/14/20

    Chatting with Former FDA and Notified Body Representatives

    R&Q Experts Reviewed the New MDCG Guidance - Here is What They Learned.

    If you were excited when the European Commission finally released four guidance documents covering Clinical Evaluation Equivalence, Clinical Evidence of Legacy Devices, and templates for the Post-market clinical follow-up (PMCF) Evaluation Reports and Plans (MDCG 2020-5-8) last week (23 …

    Q&A: EU MDR Audits: Preparing, Managing & Responding to Nonconformances

    R&Q's March 2020 webinar focused on dealing with EU MDR Audit Nonconformances. In this blog post, our knowledgeable EU MDR experts sat down to provide answers to your questions from the webinar and we hope that they will shed some light on similar questions that you may have on t…

    FDA Emergency Use Authorization (EUA) and EU MDR Article 59

    26 May 2020 - Processes, tips, and lessons learned.

    COVID-19 Continues to Impact Medical Device Manufacturing China

    Medical device companies often have a globally distributed workforce which can include remote specification developers and, more likely, manufacturing sites. In China alone, where the virus was first detected, many medical device companies have manufacturing sites, utilize contract manuf…
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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 200 employees.

    • Who are Regulatory & Quality Solutions competitors?

      Competitors of Regulatory & Quality Solutions include Ad scientiam, Sensome and NeuroPace.

    • 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.