Oriel STAT A MATRIX

    OverviewSuggest Edit

    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.

    TypePrivate
    Founded1968
    HQUnion, US
    Websiteorielstat.com

    Latest Updates

    Employees (est.) (Feb 2020)130

    Key People/Management at Oriel STAT A MATRIX

    Judith Glaser

    Judith Glaser

    Chairwoman
    Alan Marash

    Alan Marash

    CEO
    Chad Hedlund

    Chad Hedlund

    EVP, Life Sciences Consulting and Education
    Richard Vincins

    Richard Vincins

    VP, Regulatory Affairs
    Alicia Hemphill

    Alicia Hemphill

    VP, Regulatory Affairs
    Bobby McVay

    Bobby McVay

    Director, Quality Consulting
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    Oriel STAT A MATRIX Office Locations

    Oriel STAT A MATRIX has offices in Union, Buenos Aires, Niterói, Shenzhen Shi and in 6 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
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    Oriel STAT A MATRIX Financials and Metrics

    Summary Metrics

    Founding Date

    1968
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    Oriel STAT A MATRIX Operating Metrics

    Feb, 2020

    Courses

    72
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    Oriel STAT A MATRIX Online and Social Media Presence

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    Oriel STAT A MATRIX Blogs

    ISO 14971:2019 – Changes in the Current Version of ISO 14971

    The third edition of ISO 14971 was finally released in December 2019 and replaces ISO 14971:2007. Overall, no tectonic shifts have occurred – the risk management process itself remains largely unchanged. Nonetheless, there are important clarifications and updates in ISO … The post ISO 14971:2019 – C…

    “Brexit Happened” – on January 31, 2020. What’s Next for Medical Device Manufacturers?

    “Why does Britain like tea so much? Because tea leaves.” It was supposed to happen on March 29, 2019, then October 31, 2019. Well, it finally DID happen on January 31, 2020. Brexit is done. So, here’s what you need … The post “Brexit Happened” – on January 31, 2020. What’s Next for Medical Device Ma…

    Medical Device Change Control Process Best Practices

    Change is the one thing that remains constant in the medical device world and our ability to manage those ongoing changes is the only thing that keeps us from losing control of design and manufacturing processes. The FDA and other … The post Medical Device Change Control Process Best Practices appea…

    What’s the Difference Between Medical Device Clinical Evaluation and Clinical Performance? We’re Glad You Asked…

    In case you need any convincing that many forms of clinical data are a priority for European regulators and Notified Bodies, consider these numbers. The EU Medical Devices Directive (93/42/EEC) mentions the word clinical 81 times. The MDD’s replacement, the … The post What’s the Difference Betwee…

    Understanding What Is Considered a “Significant” Change Under EU MDR Article 120(3)

    The European Medical Device Regulation (EU MDR 2017/745) goes into effect on May 26, 2020. Unless you were recently dropped off by an alien spaceship, you are well aware that the EU MDR imposes strict new requirements on medical device … The post Understanding What Is Considered a “Significant” Chan…

    Yes, You’ve Evaluated Every Risk – But Are You Properly Documenting Medical Device Benefits?

    Risk. Risk. Risk. Some days it can feel as though our sole mission as medical device regulatory professionals is to raise red flags about what could go wrong. Without a doubt, safety is where the focus should be. Yet, when … The post Yes, You’ve Evaluated Every Risk – But Are You Properly Documentin…
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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 130 employees.

    • Who are Oriel STAT A MATRIX competitors?

      Competitors of Oriel STAT A MATRIX include HDI, Complispace and TEC Canada.

    • 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, Buenos Aires, Niterói, Shenzhen Shi and in 6 other locations.

    • How many offices does Oriel STAT A MATRIX have?

      Oriel STAT A MATRIX has 10 offices.