Kim, Try this FDA page: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm
Here is a higher level link concerning 510k that you may find useful: http://www.fda.gov/MedicalDevices/Devic RegulationandGuidance/HowtoMarketYourDe ice/PremarketSubmissions/PremarketNotification510k/default.htm Good luck, Carl On Mon, May 10, 2010 at 4:05 AM, Kim Boll Jensen <[email protected]> wrote: Hi FDA has certified some consultants which can help with a 510k and at the same time speed up the FDA acceptance. Where do I find a list of these certified companies? I’m looking for one in EU close to Denmark. Best regards Mr. Kim Boll Jensen Bolls Rådgivning Ved Gadekæret 11F DK-3660 Stenløse Phone: +45 48 18 35 66 [email protected] www.bolls.dk <http://www.bolls.dk/> - ---------------------------------------------------------------- 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]> - 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]>
