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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

  • 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

  • 3-D Printing/Additive Mfg.
    FDA Announces 3D Printed Medical Device Guidance

    FDA Announces 3D Printed Medical Device Guidance

    World’s first agency to provide a comprehensive technical framework for 3D printed medical product manufacturing.
    Scott Gottlieb, M.D., Commissioner, U.S. Food and Drug Administration 12.06.17

  • 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

  • Material Changes and FDA Regulation of Class II Devices

    Material Changes and FDA Regulation of Class II Devices

    How might the FDA's recent draft guidance on changes to 510(k) for an existing device impact orthopedic manufacturers?
    Online Exclusives William A. Hyman, Professor Emeritus of Biomedical Engineering, Texas A&M University, & Adjunct Professor of Biomedical Engineering, The Cooper Union 08.16.16

  • 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

  • Material Characterization and Medical Device Regulation

    Material Characterization and Medical Device Regulation

    Manufacturers need to pay attention to the material identification requirements coming out of the FDA.
    Online Exclusives William A Hyman, Professor Emeritus of Biomedical Engineering, Texas A&M University, & Adjunct Professor of Biomedical Engineering, The Cooper Union 03.25.16