Analysis

  • Standard Deviation

    The standards for radiation sterilisation of medical devices have recently been revised. Eamonn Hoxey, International Irradiation Association, explains the changes.

  • New Medical Devices Act Needs Full Funding

    The US government needs to finance a new act which is meant to improve the approval process for medical devices. Mark B Leahey of the Medical Device Manufacturers Association argues...

  • Electronic Data Regulation Under Review

    A coalition of FDA-regulated industries is petitioning the FDA. The group wishes to change the existing and proposed regulations on the use of electronic records and signatures.

  • Nanotechnology’s New Frontier

    Nanotechnology can make an important contribution to medicine. But only if innovation can be encouraged and a wary public can be reassured on its safety.

  • Ray of Hope: X-rays Promise Efficient Sterilisation

    Developments in high-energy, high-power x-ray equipment and processing facilities offer new sterilisation methods. X-ray processing, in particular, offers attractive features for disposable medical devices.

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