ISO Committee Drafts "Stand-Alone" Medical Device Quality Standard
This article was originally published in The Silver Sheet
Executive SummaryISO MEDICAL DEVICE QUALITY SYSTEMS STANDARDS are being revised to no longer reference the generic ISO 9001 quality standard. The ISO technical committee responsible for the device standard does not want to incorporate several provisions from the year 2000 version of ISO 9001 that the committee believes are not appropriate to the industry. Separating ISO 9001 from the medical device quality standard ISO 13485, however, could have serious repercussions for manufacturers and device harmonization efforts. "Customer satisfaction" requirements in ISO 9001:2000 are a particular concern to device industry stakeholders WARNING LETTERS: Internet promotions for Medtronic's Activa tremor control system "misleading," FDA claims; Thoratec QS reg cites include component testing and training documentation infractions
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