Threads Tagged with iso 13485 - medical device qms

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Threads Tagged with iso 13485 - medical device qms

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Threads Tagged with iso 13485 - medical device qms
	Discussion Thread Title / Thread Starter	Last Post or Poll Vote	Replies	Views	Forum
	ISO 13485 - List of required / needed procedures and records attached ( 1 2 3 4) ISO MAN started this discussion on 3rd November 2004	18th June 2013 12:46 PM by isolytica1	24	19,146	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Who should be the "manufacturer" in Canada? Paul Liu started this discussion on 17th June 2013	17th June 2013 10:15 PM by Paul Liu	6	167	Canada Medical Device Regulations
	ISO 13485 Class 7 Cleanroom Requirements cranky started this discussion on 24th April 2012	17th June 2013 08:39 PM by Mel Kimsey	7	1,590	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	The difference between PN-EN ISO 13485 and EN ISO 13485 CMDCAS MariuszPoland started this discussion on 14th June 2013	17th June 2013 01:44 PM by Sarah Stec	7	285	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Technical File vs. Design Dossier? Class II and Class III Medical Devices ( 1 2) jdy11 started this discussion on 31st July 2008	17th June 2013 04:53 AM by MariuszPoland	8	17,784	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Taiwan Medical Device Product Approval Process using a Subcontractor ( 1 2) ISO 13485 - Medical started this discussion on 5th February 2010	14th June 2013 09:50 PM by Ajit Basrur	10	2,074	Other Medical Device Related Standards
	Is this Quality Policy acceptable in the context of ISO 13485? ( 1 2 3) SGquality started this discussion on 7th June 2013	13th June 2013 08:34 PM by SGquality	22	654	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Can ISO 13485 be implemented in just one section of a business? lenwelshlass started this discussion on 11th June 2013	11th June 2013 04:07 PM by b9ofus	4	162	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Internal Auditor Qualifications – ISO13485 vs. ISO9001 ( 1 2) kfric started this discussion on 9th January 2012	8th June 2013 06:14 PM by db	8	1,089	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	CMDCAS versus ISO 13485 - What are the additional requirements ( 1 2 3) Bill Goss started this discussion on 19th October 2010	5th June 2013 04:40 PM by IVD_RA	21	5,442	Canada Medical Device Regulations
	How to streamline different documents in a multi plant ISO13485 QMS ( 1 2) paulag started this discussion on 28th May 2013	29th May 2013 06:47 AM by Kevin Mader	8	298	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	ISO 13485 - The use of virtual offices (everything is sub-contracted) Wheeljem started this discussion on 27th May 2013	29th May 2013 04:56 AM by Wheeljem	4	323	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Complete Cycle for Complaint Process - Idea Searching 20130523 started this discussion on 22nd May 2013	28th May 2013 02:44 PM by yodon	7	512	Customer Complaints including ISO 10002
	Corrective Actions Root Causes from Surveillance Audit Findings ehoqa started this discussion on 24th May 2013	24th May 2013 04:38 PM by insect warfare	3	261	Nonconformance and Corrective Action
	AS9100:2009 compared to ISO 13485 Pigmy started this discussion on 22nd May 2013	23rd May 2013 01:34 PM by Mikishots	3	208	AS9100, Nadcap and related Aerospace Standards and Requirements
	ISO 13485 and IQ (Installation Qualification), OQ (Operational Qualification) ( 1 2 3) chasf started this discussion on 3rd March 2008	22nd May 2013 12:39 PM by bcsnave	20	14,323	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Is a Quality Manual a requirement for FDA registration? rvanelli started this discussion on 13th May 2013	21st May 2013 08:25 AM by rvanelli	5	296	US Food and Drug Administration (FDA)
	Scope of ISO 13485 Certification needs the word Production. ( 1 2) dampiro started this discussion on 15th May 2013	16th May 2013 10:13 PM by Ronen E	9	367	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
	Device Master Record Requirements for Component Manufacturer ISODOC started this discussion on 14th May 2013	15th May 2013 09:10 PM by Ronen E	6	285	US Medical Devices (21 CFR part 820)
	FAQ Thread: News on the ISO 13485 revision - 2011 - 2012 (now 2014?) ( 1 2 3 4 5 6 ... Last Page) Marcelo Antunes started this discussion on 14th April 2011	13th May 2013 09:55 PM by Marcelo Antunes	72	15,320	ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems

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