US Medical Devices (21 CFR part 820)

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US Medical Devices (21 CFR part 820)

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	FAQ Thread: Finding Medical Device Listing Numbers on the USA's FDA site Exact started this discussion on 3rd December 2009	22nd April 2012 04:30 PM by MIREGMGR	6	7,606
	FAQ Thread: ISO 13485, ISO 14971 and other Medical Device Related Forums Marc started this discussion on 18th October 2009	18th October 2009 08:03 PM by Marc	0	3,380
	FAQ Thread: 21 CFR Part 820 - QUALITY SYSTEM REGULATION Ajit Basrur started this discussion on 22nd April 2008	22nd April 2008 10:29 AM by Ajit Basrur	0	6,894
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	What documents would an FDA auditor want to see in an FDA Audit of Quality System apriljoyc started this discussion on 23rd May 2013	23rd May 2013 09:39 PM by harry	4	93
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	Retrospective DHF for an old non-registered device Krthna started this discussion on 22nd May 2013	23rd May 2013 05:43 PM by Ronen E	3	118
	FDA Reclassification of Medical Devices - Class III device down to Class II deuce64 started this discussion on 23rd May 2013	23rd May 2013 04:12 PM by deuce64	0	66
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	FDA 510(k) Submission Tests - Posterior Cervical Spinestem dogbural started this discussion on 9th May 2013	10th May 2013 02:14 AM by Stijloor	1	137
	US FDA Unique Device Identification (UDI) Proposed Rule ( 1 2 3) sreenu927 started this discussion on 5th July 2012	9th May 2013 01:35 PM by lboll	16	1,468
	Interpretation of MDR Reportable Event - FDA guidance on Medical Device Reporting ( 1 2) LievenDW started this discussion on 21st May 2010	8th May 2013 10:26 AM by MIREGMGR	13	3,570
	FDA Guidance on Metal Injection Molding process validation bwaters started this discussion on 1st May 2013	2nd May 2013 08:28 AM by Statistical Steven	2	195
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	Update DHF (Device History Record) when DMR (Device Master Record) changes? ( 1 2) Watchwait started this discussion on 12th May 2008	23rd April 2013 08:15 PM by Ronen E	13	5,367
	DMR-Device Master Record vs DHF-Design History File vs DHR-Device History Record ( 1 2 3 4 5 6) QE started this discussion on 11th June 2010	23rd April 2013 04:27 PM by sagai	41	16,992
	FDA issues draft guidance to replace G95-1 (Application of ISO 10993) MIREGMGR started this discussion on 23rd April 2013	23rd April 2013 08:40 AM by MIREGMGR	0	192
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