Search Results for 'medical device'

Search For:
Refine by Dates:
From: To:
Refine By Content:

Buyers Guide Companies

View All Buyers Guide Companies »


  • Modifications to a Cleared Device: Letter to File or New 510(k)?

    Modifications to a Cleared Device: Letter to File or New 510(k)?

    Change is good, right? Most orthopedic manufacturers have been working under the ISO 13485 umbrella, which stresses the need for continuous improvement. Once a device is in commercial distribution, there are valuable lessons to be learned. Shouldn&rs…
    Linda Braddon, Ph.D., President and CEO, Secure BioMed Evaluations 05.29.18

  • 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

  • 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

  • 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

  • Using Simulation in Medical Device Design

    Using Simulation in Medical Device Design

    Image-based modeling and simulation are becoming increasingly common for device design.
    Gareth James, Contributing Writer 11.17.15

  • Lean Medical Device Manufacturing in 3-D

    Lean Medical Device Manufacturing in 3-D

    Following a few key steps can help companies see the 'Lean' light
    Online Exclusives Matt Burba & Lani Watson, Orchid Orthopedic Solutions 07.23.12