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  • How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations

    How Identifying Gaps in Clinical Data Can Ease the Transition to New Regulations

    As of 2017, the European medical device market was estimated  at $126 billion, the second largest worldwide, comprising 27 percent of the global market. The European market trails only the United States, which accounts for roughly 43 percent of…
    Mike Goodson, Associate Director, Regulatory Affairs, MCRA LLC 09.17.19

  • Biologics
    Study: Regulations Limit Orthopedic Biomaterials Across U.S., European Markets

    Study: Regulations Limit Orthopedic Biomaterials Across U.S., European Markets

    Biomaterials increasingly are becoming popular with patients who want to avoid surgical implantation of permanent devices or hardware.
    Business Wire 06.18.19

  • Biologics
    The ABCs of HCT/Ps

    The ABCs of HCT/Ps

    Navigating the complex regulatory pathway of human cell and tissue products.
    Lindsay Kleinwaks, Ph.D., Associate, Regulatory Affairs, MCRA 05.23.19

  • 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

  • Software & Quality
    The Importance of an Integrated QMS Within Regulatory Industries

    The Importance of an Integrated QMS Within Regulatory Industries

    The life sciences market is constantly evolving, and automated quality and compliance solutions must follow suit. The ability to interact, collaborate, and coordinate across the board is key to uncovering gaps in processes and creates visibility betw…
    Emily Ysaguirre, Content Marketing Writer, VERSE Solutions 05.19.17

  • The Regulation of Advanced Manufacturing

    The Regulation of Advanced Manufacturing

    I grew up in Roseville, Mich., at a time when manufacturing was central to the local economy. Back then, heavy industrial manufacturing was king. But over the years, the art of mass production has changed significantly. From automation and robotics t…
    James A. Dunning, QPC Services 08.09.16

  • New Products and Regulations Test the Testers

    New Products and Regulations Test the Testers

    Changes in biocompatibility testing affect genotoxicity, bone replacement materials and other areas.
    08.31.10