Posted for Dave Osborn
Subject: FW: [PSES]: Any good safety consultants out there? List-Post: [email protected] List-Post: [email protected] List-Post: [email protected] Date: Wed, 17 Feb 2010 20:10:49 +0100 From: Osborn, Dave <[email protected]> To: [email protected] <[email protected]> CC: Mike W. Schmidt <[email protected]> Hi Mike, Sorry to bother you, but I cannot post since I use my ieee alias on the list serve. Can you please get this to Bryce as it is an answer to his question. Best regards, Dave Osborn Secretary, ISO TC 121/SC 3 Manager, International Standards Standards & Regulations Department Philips Healthcare 3000 Minuteman Road, Bldg 4 Andover, MA 01810-1099 USA PH-158 3178 Tel: +1 978 659 3178 Fax: +1 978 659 3819 E-mail: [email protected] *From:* Mike W. Schmidt [mailto:[email protected]] *Sent:* Wednesday, February 17, 2010 12:41 PM *To:* [email protected] *Cc:* Osborn, Dave *Subject:* FW: [PSES]: Any good safety consultants out there? Dear Bryce, As you will see below I was forwarded your email by Dave Osborn (thanks Dave!). I have been in the medical device Safety, Compliance (product and process) and Regulatory consulting business since 2003 and have been involved with these disciplines since 1983. In addition to being the Secretary of IEC SC 62D, I convened one of the working groups that wrote 60601-1: 2005 and am an expert for the maintenance teams responsible for ISO 14971 and for 60601-1-4 (now clause 14 of 60601-1). I am also a member of the NFPA 99 Committee and AAMI’s Electrical Safety Committee (responsible for ANSI/AAMI ES 60601-1). I would be pleased to provide your organization with support in updating your compliance and in selecting the appropriate certification body. If you’d like more information about myself and the services I offer, my web site is www.devicecompliance.com <http://www.devicecompliance.com> (take note that clicking on the text “download a free sample…” at the top of the home page will get you a sample of the matrix I use and sell to help make the 60601-1 2^nd to 3^rd Edition transition). Feel free to contact me by email or phone if you’d like to discuss how I can help in detail. Best regards, Mike Schmidt Principal Consultant Strategic Device Compliance Services *From:* Osborn, Dave [mailto:[email protected]] *Sent:* Tuesday, February 16, 2010 6:40 PM *To:* Mike W. Schmidt *Subject:* FW: [PSES]: Any good safety consultants out there? *From:* [email protected] [mailto:[email protected]] *On Behalf Of *Bryce Stammerjohan *Sent:* Tuesday, February 16, 2010 6:34 PM *To:* [email protected] *Subject:* [PSES]: Any good safety consultants out there? Group, Can anyone recommend (off-list responses welcome, if you are uncomfortable) a consultant(s) to help a med device mfr with transition to IEC/EN/ANSI 60601-1 3^rd Ed. and also with choosing a non-UL NRTL for US safety work? Thanks, Bryce - 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 <[email protected] <mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. 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If you are not the intended recipient, please contact the sender by return e-mail and destroy all copies of the original message. - 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 <[email protected] <mailto:[email protected]>> All emc-pstc postings are archived and searchable on the web at http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected] <mailto:[email protected]>> Mike Cantwell <[email protected] <mailto:[email protected]>> For policy questions, send mail to: Jim Bacher <[email protected] <mailto:[email protected]>> David Heald <[email protected] <mailto:[email protected]>> - 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 <[email protected]> All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc Graphics (in well-used formats), large files, etc. can be posted to that URL. Website: http://www.ieee-pses.org/ Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas <[email protected]> Mike Cantwell <[email protected]> For policy questions, send mail to: Jim Bacher: <[email protected]> David Heald: <[email protected]>
