OT: Any of you documenting the same product as IVD and non-IVD equipment?
Hi I just found out that my product manual should be marked with the IVD symbol for US customers. For the rest of the world the IVD doesn't apply. The current solution is to have the same manuals in two versison one with and one without the IVD logo on the rear page. That means two order numbers, additons to price lists, two brochures, two CDs with the manual etc. Do any of you know of an operational way of handling this? My first suggestions was to have 1 manual and in front of or above the IVD logo have something like applicable to the US market but that idea was discarded by regulatory affairs. I looking forward to hearing any suggestions offline Med venlig hilsen - Best regards Verner Andersen Technical Writer Radiometer Medical ApS Phone +45 3827 3612 Fax +45 3827 2727 [EMAIL PROTECTED] Radiometer Medical ApS Akandevej 21 2700 Bronshoj Denmark Phone: +45 38 27 38 27 CVR: 27 50 91 85 This message (including any attachments) contains confidential and/or proprietary information intended only for the addressee. Any unauthorized disclosure, copying, distribution or reliance on the contents of this information is strictly prohibited and may constitute a violation of law. If you are not the intended recipient, please notify the sender immediately by responding to this e-mail, and delete the message from your system. If you have any questions about this e-mail please notify the sender immediately. ___ You are currently subscribed to Framers as [EMAIL PROTECTED] Send list messages to [EMAIL PROTECTED] To unsubscribe send a blank email to [EMAIL PROTECTED] or visit http://lists.frameusers.com/mailman/options/framers/archive%40mail-archive.com Send administrative questions to [EMAIL PROTECTED] Visit http://www.frameusers.com/ for more resources and info.
Re: OT: Any of you documenting the same product as IVD and non-IVD equipment?
What's IVD? On Wed, Oct 1, 2008 at 7:56 AM, Andersen, Verner Engell VEA [EMAIL PROTECTED] wrote: Hi I just found out that my product manual should be marked with the IVD symbol for US customers. For the rest of the world the IVD doesn't apply. -- John Posada Senior Technical Writer NYMetro STC President 'Half this game is ninety percent mental.' -- Danny Ozark, Philadelphia Phillies manager ___ You are currently subscribed to Framers as [EMAIL PROTECTED] Send list messages to [EMAIL PROTECTED] To unsubscribe send a blank email to [EMAIL PROTECTED] or visit http://lists.frameusers.com/mailman/options/framers/archive%40mail-archive.com Send administrative questions to [EMAIL PROTECTED] Visit http://www.frameusers.com/ for more resources and info.
OT: Any of you documenting the same product as IVD and non-IVD equipment?
What's IVD? On Wed, Oct 1, 2008 at 7:56 AM, Andersen, Verner Engell VEA wrote: > Hi > > I just found out that my product manual should be marked with the IVD > symbol for US customers. For the rest of the world the IVD doesn't > apply. -- John Posada Senior Technical Writer NYMetro STC President 'Half this game is ninety percent mental.' -- Danny Ozark, Philadelphia Phillies manager
OT: Any of you documenting the same product as IVD and non-IVD equipment?
Hi I just found out that my product manual should be marked with the IVD symbol for US customers. For the rest of the world the IVD doesn't apply. The current solution is to have the same manuals in two versison one with and one without the IVD logo on the rear page. That means two order numbers, additons to price lists, two brochures, two CDs with the manual etc. Do any of you know of an operational way of handling this? My first suggestions was to have 1 manual and in front of or above the IVD logo have something like "applicable to the US market" but that idea was discarded by regulatory affairs. I looking forward to hearing any suggestions offline Med venlig hilsen - Best regards Verner Andersen Technical Writer Radiometer Medical ApS Phone +45 3827 3612 Fax +45 3827 2727 verner.andersen at radiometer.dk Radiometer Medical ApS Akandevej 21 2700 Bronshoj Denmark Phone: +45 38 27 38 27 CVR: 27 50 91 85 This message (including any attachments) contains confidential and/or proprietary information intended only for the addressee. Any unauthorized disclosure, copying, distribution or reliance on the contents of this information is strictly prohibited and may constitute a violation of law. If you are not the intended recipient, please notify the sender immediately by responding to this e-mail, and delete the message from your system. If you have any questions about this e-mail please notify the sender immediately.
