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Follow on Google News | How adequate is the European regulatory framework for breast implants?Haroon Atchia from Quality First International examines the regulatory framework that is at the core of one of the biggest current international health scandals
Haroon Atchia - CEO of the London-based medical device consultancy Quality First International - has written a research summary on the PIP breast implant case. In his summary he examines the questions: Is the product in question actually inferior and faulty? Are current European regulations adequate for examining and regulating breast implants? The author also reviews the origin of the regulatory problem and asks whether the authorities involved in ensuring the safety of the public acted appropriately and timeously. Mr Atchia’s summary also looks briefly at the US Food and Drug Administration breast augmentation approval process, which is instructive in understanding the significant differences between the approval process in the USA versus the system that may have allowed the on-going PIP situation. Mr Atchia has also written a Guest Editorial - which will be published in the November 2012 issue of the Journal of Medical Device Regulation (www.globalregulatorypress.com) End
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