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  • Your EU Medical Devices Regulation (MDR) Questions, Answered

    Your EU Medical Devices Regulation (MDR) Questions, Answered

    The upcoming EU Medical Devices Regulation (MDR) changes are significant, potentially impacting device classification and the need for clinical data. It’s imperative organizations act now to meet these requirements in 2020 and beyond. Portfolio…
    Nancy Morrison, Director of Regulatory Affairs, Regulatory and Quality Solutions LLC (R&Q) 03.21.18

  • Software & Quality
    Medical Device Quality: Why Software Is More Challenging Than Hardware

    Medical Device Quality: Why Software Is More Challenging Than Hardware

    The U.S. Food and Drug Administration’s (FDA) Quality System Regulation 21 CFR Part 820.30(g) states, “Design validation shall include software validation and risk analysis, where appropriate.” The words, “where appropriate,&r…
    Dan Goldstein, Manager, Quality Assurance, Musculoskeletal Clinical Regulatory Advisors 03.21.18

  • The Impact of U.S. Regulation on Medical Device Innovation

    The Impact of U.S. Regulation on Medical Device Innovation

    Passion, inspiration, perseverance, altruism, and need have historically been the factors driving innovators. During World War II, antibiotics were scarce and chronic osteomyelitis and bone deficiencies such as non-unions and deformities were common.…
    Patricia Kontoudis, Associate, Regulatory Affairs, Musculoskeletal Clinical Regulatory Advisers LLC 02.12.18

  • Medical Device Tax Suspended for Two Years...Again

    Medical Device Tax Suspended for Two Years...Again

    Now delayed until Jan. 1, 2020, the medical device industry cheered the last-minute legislation.
    Sam Brusco, Associate Editor 01.23.18

  • Software & Quality
    4 FAQs: Medical Device Single Audit Programs

    4 FAQs: Medical Device Single Audit Programs

    Audits and inspections are essential parts of medical device manufacturing. Yes, they can be a pain point for many organizations since they require a lot of preparation and may happen unexpectedly. But they are an essential way to keep manufacturers…
    Alexa Sussman, Content Marketing Writer, EtQ 08.15.17

  • Software & Quality
    The Benefits of Electronic Medical Device Reporting

    The Benefits of Electronic Medical Device Reporting

    Most tend to think of safety and quality in two separate spheres. In truth, these two are closely linked—having a total safety mindset often means having a quality mindset. Someone consistently acting in a high-risk manner will likely create pr…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 02.23.17

  • Biocompatibility & Testing
    New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants

    New FDA Guidance for 510(k) Submission of Orthopedic Medical Implants

    The document could have a significant impact on the testing regimen for implant device manufacturers.
    Martell Winters, Senior Scientist and Consulting Manager; Quinton Inglet, Section Leader, Bacterial Endotoxin Testing, Nelson Laboratories 11.22.16

  • Top 10 Orthopedic Device Companies

    Top 10 Orthopedic Device Companies

    Digital health has been making headlines for several years now, but it’s finally starting to be reflected in ODT’s Top 10.
    Sean Fenske, Editor; Michael Barbella, Managing Editor; Sam Brusco, Associate Editor 08.15.16

  • Driving a Successful Medical Device Product Development Cycle

    When you set out to bring a new medical device to market, avoid spinning your wheels—follow a tried-and-true road map.
    Dawn Lissy, Contributing Writer 08.05.15