Hello Gang, The situation with the Medical Devices Directive is very clear. The manufacturer is NOT the organization that builds something, it is the organization whose name is on the device.
Hence an organization, as in the previous example -- Boots, whose name is on the device, is the organization responsible for the device and is considered the (medical device) manufacturer. If the device is of classification greater than Class 1, that organization is required to have a 'certified' quality system and to fulfill all of the relevant requirements of the directive, one of which is to issue a DoC. In order to be able to do this when you are not he organization that builds something, requires careful contracts and audits to ensure that you the organization whose name is on the device have sufficient controls to allow you to ensure the fulfillment of all of the requirements of the relevant directives. Best regards, Dave Osborn PM-CMS Philips Medical Systems +1 978 659 3178 fax +1 978 685 5624 dave.osb...@philips.com This message is from the IEEE EMC Society Product Safety Technical Committee emc-pstc discussion list. Visit our web site at: http://www.ewh.ieee.org/soc/emcs/pstc/ To cancel your subscription, send mail to: majord...@ieee.org with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: emc-p...@hypercom.com Dave Heald: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org Archive is being moved, we will announce when it is back on-line. All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
