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  • Extremities | Materials | Spine/Neurology
    In Situ Cured Silicone Could Enable Personalized Implants

    In Situ Cured Silicone Could Enable Personalized Implants

    Medical-grade silicone is a highly valued, versatile biomaterial widely used for medical implants. Often associated with applications such as cardiovascular pacemakers, cochlear implants, hydrocephalus shunts, implantable infusion pumps, and even int…
    Brian Reilly and Jim Lambert, Ph.D., NuSil, an Avantor brand 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

  • DJO Sales Decline Slightly in Q2, Surgical Implant Sales Up 12 Percent

    San Diego, Calif.-based DJO Global Inc. has released financial results for its second quarter (ended June 27). The quarter achieved net sales of $310.8 million, reflecting a decline of 1 percent, compared with net sales of $313.9 million for the s…

  • Five Medical Device Risk Management Myths … And How to Avoid Them

    Elvis lives. The moon landing was staged in a Hollywood studio. Brett Favre is too old to play pro football. Legions of believers tenaciously have held these views, which have proven to be akin to urban myths. Before we snicker at those harboring…

  • Post-Riegel: Device safety and risk management

    All the same risk management strategies that made sense pre-Riegel still make sense. For life science firms engaged in medical product outsourcing though, supply chain management becomes even more vital. Those firms outsourcing manufacturing of co…