Hi, What is the software for? It is possible that it will fall under the Medical Device Directive or IVDD (and FDA) if it is used in the medical field.
If you should have any questions or comments, please feel free to contact me. Sincerely, Ned Devine Entela, Inc. 3033 Madison Ave. SE Grand Rapids, MI 49548 Phone: 616 248 9671 Fax: 616 574 9752 e-mail: [email protected] www.entela.com Entela, Inc. A Certified Woman Owned Business -----Original Message----- From: [email protected] [mailto:[email protected]] Sent: Tuesday, December 10, 2002 8:35 AM To: [email protected] Subject: CE marking software product Dear Group, We wish to market a product consisting of a CD rom+ software, serial cable and RS232 Interface Converter ('bought in' component and CE marked). Are there any CE marking requirements for this type of product? If so, which directives do they come under? Many thanks Ian Unwin ________________________________________________________________________ This email has been scanned for all viruses by the MessageLabs SkyScan service. This electronic message contains information from Servomex which may be privileged or confidential. The information is intended to be for the use of the individual(s) or entity named above. If you are not the intended recipient be aware that any disclosure, copying, distribution or use of the contents of this information is prohibited. If you have received this electronic message in error, please notify us immediately. Activity and use of the Servomex E-mail system is monitored to secure its effective operation and for other lawful business purposes. Communications using this system may also be monitored and may be recorded to secure effective operation and for other lawful business purposes. ------------------------------------------- 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list" ------------------------------------------- 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: [email protected] with the single line: unsubscribe emc-pstc For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://ieeepstc.mindcruiser.com/ Click on "browse" and then "emc-pstc mailing list"
