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  • 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

  • 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

  • Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Comparing cGMP Pharma vs. Device: Subpart A – General Provisions

    Since they are both part of the healthcare industry, you’d think pharmaceutical and medical device companies would have a better understanding of each other’s current Good Manufacturing Practices (cGMP) requirements. Think again. Despite…
    James A. Dunning, Owner, QPC Services LLC 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

  • 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

  • The Risk of Using Noncompliant Temporary Labor in Medical Device Manufacturing

    No medical device manufacturer wants to put out an inferior product. It’s bad for business. It’s costly. Plus, it often leads to recalls, penalties, litigation and even wrongful-death lawsuits. A bad product is a big deal. One producti…
    Terry Hamm, Contributing Writer, GW Plastics 12.01.14

  • 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