In the blog

  • FDA commissions review of the 510(k) process

    Very interested to read recently that the FDA has commissioned the US Institute of Medicine (IOM) to review the 510(k) process. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm183497.htm Whilst the review isn’t due to be complete until March 2011 I’ve already seen several articles from industry associations defending the current process. As part of the IOM there will be two public [...]

  • BSI acquires German Notified Body

    BSI has acquired German based Notified Body EUROCAT. EUROCAT is accredited for the certification of devices, IVD’s and active implantable’s and also offers product testing. See the official BSI press release here .

  • BSI adds to Fast Track service offering

    BSI has added a new accelerated programme for device manufacturers (CE-Dedicated Fast Track) looking to bring their product to market quickly.
    CE-Dedicated FastTrack offers reviews within 45 working days or less and does this by dedicating a reviewer to the project and by performing the review off-site. This is the 4th  such initiative BSI have introduced [...]

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