Specifies requirements for a quality management system where an organization needs todemonstrate its ability to provide medical devices and related services that consistently meetcustomer requirements and regulatory requirements applicable to medical devices and relatedservices.
Keywords: medical device, quality management system
This product is related to: SEPT ANSI/AAMI/ISO 13485:2003 CHECKLIST - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes IEC 62304 Ed. 1.0 b:2006 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes FDA GUIDANCE 4 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes SEPT IEC 62304 CHECKLIST - Prod 40 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes This product replaces:ANSI/AAMI/ISO 13485:1996 - Quality systems - Medical devices - Particular requirements for the application of ISO 9001
People Who Bought This Also Bought: ANSI/AAMI/ISO 14971:2007 (R2010)- Medical Devices - Application of Risk Management to Medical DevicesISO 389-5:2006- Acoustics - Reference zero for the calibration of audiometric equipment - Part 5: Reference equivalent threshold sound pressure levels for pure tones in the frequency range 8 kHz to 16 kHzISO 389-6:2007- Acoustics - Reference zero for the calibration of audiometric equipment - Part 6: Reference threshold of hearing for test signals of short durationANSI/AAMI ES60601-1:2005 and ES60601-1:2005/C1:2009- Medical electrical equipment, Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)IEC 60601-1-8 Ed. 2.0 b:2006- Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsIEC 60601-1-4 Ed. 1.1 b:2000- Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems CONSOLIDATED EDITIONISO 2859-3:2005- Sampling procedures for inspection by attributes - Part 3: Skip-lot sampling proceduresISO 9001:2000- Quality management systems -- RequirementsIEC 60645-3 Ed. 2.0 b:2007- Electroacoustics - Audiometric equipment - Part 3: Test signals of short duration SEPT ANSI/AAMI/ISO 13485:2003 CHECKLIST- EVIDENCE PRODUCT CHECKLIST for ANSI/AAMI/ISO Standard 13485:2003 Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes ** SAVE OVER 30%, LIMITED TIME OFFER