Forgot to say that, while the 2016 edition can be used now, accreditation and reports per 2016 edition dependent on your particular registrar update schedule, lunar phase, and planetary alignments relative to the Klingon Home-world.
https://standards.cen.eu/dyn/www/f?p=204:110:0::::FSP_PROJECT:37957&cs=1B04E3A6EA841FF02235DCA86690F765D Brian -----Original Message----- From: Brian O'Connell Sent: Wednesday, January 18, 2017 8:27 AM To: 'Stephen Whalen'; EMC-PSTC@LISTSERV.IEEE.ORG Subject: RE: [PSES] ISO 13485-2016 All hail the Goddess of Search. March 2019 per https://standards.cen.eu/dyn/www/fp=204:110:0::::FSP_PROJECT,FSP_ORG_ID:37957,581003&cs=10ED77AEC2D379A0A511B4BB99F861487 Brian From: Stephen Whalen [mailto:scwha...@bellsouth.net] Sent: Wednesday, January 18, 2017 7:17 AM To: EMC-PSTC@LISTSERV.IEEE.ORG Subject: [PSES] ISO 13485-2016 All, I am helping a client with medical device manufacturing QMS. ISO 13485 - 2016 has been released however 2016 version is not listed as harmonized with EU. Does anyone know if 2016 version is acceptable now for CE approval? https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en Regards, Stephen - ---------------------------------------------------------------- This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. To post a message to the list, send your e-mail to <emc-p...@ieee.org> All emc-pstc postings are archived and searchable on the web at: http://www.ieee-pses.org/emc-pstc.html Attachments are not permitted but the IEEE PSES Online Communities site at http://product-compliance.oc.ieee.org/ can be used for graphics (in well-used formats), large files, etc. Website: http://www.ieee-pses.org/ Instructions: http://www.ieee-pses.org/list.html (including how to unsubscribe) List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <sdoug...@ieee.org> Mike Cantwell <mcantw...@ieee.org> For policy questions, send mail to: Jim Bacher: <j.bac...@ieee.org> David Heald: <dhe...@gmail.com>
