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Technion Israel Institute of Technology
Latest From Steris Corp.
The largest medical device merger ever will not be materially impacted by the Treasury Department's new rules to thwart tax-inversion deals.
FDA has found that validation test data for three automated endoscope reprocessors – including Medivators’ Advantage Plus and DSD Edge, and Steris’ System 1E Liquid Chemical Sterilant Processing System – are adequate.
A Long, Twisted Path To Revision: How The 'Unusual' Makeover Of ISO 13485 Will Impact Device Manufacturers – And Why There Isn't Much They Can Do About It Now
Staying the course has been an ongoing challenge for the International Organization for Standardization as it works overtime to revise ISO 13485, one of the most widely used quality system standards in medical device manufacturing. There have been obstacles to the latest revision of ISO 13485: some ISO member-countries voted against drafts of the standard for no apparent reason; an inordinate number of industry comments had to be reviewed one-by-one; and the document's redo bumped up against the revision of an even bigger, broader international standard, ISO 9001 – just to name a few headaches – but ISO's Technical Committee 210 hopes to finish a final draft of the standard at an upcoming meeting in the UK.
The companies plan to contest the Federal Trade Commission's action, although they say they have yet to see FTC's formal complaint. The deal, valued at $1.9 billion, would allow U.S.-based Steris to reduce its corporate tax rate by redomiciling to Synergy's home in the U.K., creating a $2.6 billion entity.
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