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    Oriel STAT A MATRIX is a global provider of quality improvement training and consulting services. The company primarily focuses on medical device regulatory compliance, quality management, auditing, and training. Its solutions help life sciences companies comply with domestic and international regulations, prepare product submissions, and improve process quality.

    HQUnion, US

    Latest Updates

    Employees (est.) (Oct 2020)132
    Cybersecurity ratingBMore

    Key People/Management at Oriel STAT A MATRIX

    Judith Glaser

    Judith Glaser

    Alan Marash

    Alan Marash

    Chad Hedlund

    Chad Hedlund

    EVP, Life Sciences Consulting and Education
    Richard Vincins

    Richard Vincins

    VP, Regulatory Affairs
    Alicia Hemphill

    Alicia Hemphill

    VP, Regulatory Affairs
    Barry Schnell

    Barry Schnell

    Sr. VP, Business Development
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    Oriel STAT A MATRIX Office Locations

    Oriel STAT A MATRIX has offices in Union, San Martin, Buenos Aires, Niterói and in 7 other locations
    Union, US (HQ)
    1095 Morris Ave #103B
    Buenos Aires, AR
    4 Piso, San Martín 575
    Niterói, BR
    RU Taper, 121-Santa Rosa
    Shenzhen Shi, CN
    88 Fuhua 3rd Rd, Fu Tian C B D, Futian Qu
    San Juan de Tibás, CR
    Urbanización González Truque
    Mumbai, IN
    4, Bandra Kurla Complex Rd, G Block BKC, Bandra Kurla Complex, Bandra East
    Show all (12)

    Oriel STAT A MATRIX Financials and Metrics

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    Oriel STAT A MATRIX Operating Metrics

    Feb, 2020


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    Oriel STAT A MATRIX Cybersecurity Score

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    Oriel STAT A MATRIX Online and Social Media Presence

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    Oriel STAT A MATRIX Blogs

    Understanding EU MDR Clinical Evidence Required for “Legacy” Medical Devices as Outlined in MDCG 2020-6

    Ever since the release of MEDDEV 2.7-1 rev 4 in 2016 and the publication of the European Medical Device Regulation (EU MDR) in 2017, manufacturers have been coming to grips with the realization that their existing clinical data was not going to cut it in the new EU MDR paradigm. As existing Medical …


    The post Orieltest appeared first on Oriel STAT A MATRIX Blog.

    Thinking About Moving Your Medical Device Manufacturing Facility Back to the US or Another Country?

    There comes a time in the evolution of every medical device company when big changes need to be made with regard to manufacturing, most significantly where it’s done. There are many strategic factors to consider when moving medical device production … The post Thinking About Moving Your Medical Devi…

    What Notified Bodies Look for When Reviewing Your Medical Device Technical Documentation Under the EU MDR

    If you’ve been involved in medical device regulatory affairs for 5+ years, you know all too well that the requirements around technical documentation associated with European CE Marking have tightened. The June 2016 release of guidance document MEDDEV 2.7-1 rev … The post What Notified Bodies Look …

    The EU MDR Has Been Pushed Out to 2021. That’s a Golden Opportunity…

    Some will yawn, some will sigh in relief, and some will express frustration that their mad dash to become compliant with the EU Medical Device Regulation (2017/745) deadline was for naught. But few can deny that in light of COVID-19, … The post The EU MDR Has Been Pushed Out to 2021. That’s a Golden…

    COVID-19 Regulatory Resources for Medical Device and IVD Manufacturers

    The FDA and other global regulators have been rapidly publishing information intended to help medical device and IVD manufacturers respond to the COVID-19 crisis.  On this page we are collecting helpful links to various regulatory authority web pages and other … The post COVID-19 Regulatory Resource…
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    Oriel STAT A MATRIX Frequently Asked Questions

    • When was Oriel STAT A MATRIX founded?

      Oriel STAT A MATRIX was founded in 1968.

    • Who are Oriel STAT A MATRIX key executives?

      Oriel STAT A MATRIX's key executives are Judith Glaser, Alan Marash and Chad Hedlund.

    • How many employees does Oriel STAT A MATRIX have?

      Oriel STAT A MATRIX has 132 employees.

    • Who are Oriel STAT A MATRIX competitors?

      Competitors of Oriel STAT A MATRIX include HDI, Startup Manufactory and Chad Hymas Communications.

    • Where is Oriel STAT A MATRIX headquarters?

      Oriel STAT A MATRIX headquarters is located at 1095 Morris Ave #103B, Union.

    • Where are Oriel STAT A MATRIX offices?

      Oriel STAT A MATRIX has offices in Union, San Martin, Buenos Aires, Niterói and in 7 other locations.

    • How many offices does Oriel STAT A MATRIX have?

      Oriel STAT A MATRIX has 12 offices.