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SEPT - FDA MED DEV SW CK/L* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR FDA GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES - 2005 REVISION; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2011-11-29
Description: General Principles of the checklist "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" This checklist was prepared by analyzing each clause of this guidelines for the keywords that signify a: Procedure Plan Records Document (Including Lists, Manuals, Reports, Scripts and Specification) Audit Review This checklist specifies evidence that is unique.
SEPT - FDA MED DEV SW CK/L - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR FDA GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES - 2005 REVISION Organization: SEPT
Date: 2011-11-29
Description: General Principles of the checklist "FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" This checklist was prepared by analyzing each clause of this guidelines for the keywords that signify a: Procedure Plan Records Document (Including Lists, Manuals, Reports, Scripts and Specification) Audit Review This checklist specifies evidence that is unique.
SEPT - FDA OTS SW STD CK/L* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “GUIDANCE FOR INDUSTRY, FDA REVIEWERS AND COMPLIANCE ON OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES” - INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2012-01-04
Description: Documnet Number - FDA INDUSTRY GUIDANCE WORD SEPT Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: "Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices" As Amended By: "Guidance for Industry, FDA Reviewers and Compliance On Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005.
HHS - FDA OFF-THE-SHELF SW - GUIDANCE FOR INDUSTRY, FDA REVIEWERS AND COMPLIANCE ON OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES Organization: HHS
HHS - FDA PRE MARKET SUBMISSION - GUIDANCE FOR INDUSTRY AND FDA STAFF GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES Organization: HHS
SEPT - MED DEVICE CHECKLIST KIT - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - MEDICAL DEVICE SOFTWARE CHECKLIST KIT - INCLUDES; ISO 13485: 2016, IEC 62304: 2015, UL 1998: 2004, ISO/IEC 90003: 2014, ISO 9001: 2015, FDA SW VAL STD CK/L, FDA OTS SW STD CHK/L, FDA MED DEV SW CK/L - SAVE 40% OVER BUYING INDIVIDUAL DOCUMENTS - REPLACES PRODUCT NUMBER 87: TO PURCHASE CALL 1-800-854-7179 USA/CANADA OR 303-397-7956 WORLDWIDE Organization: SEPT
Date: 2016-03-01
Description: Checklist for Guidance for Industry, FDA Reviewers and Compliance on Off-the Shelf Software Use in Medical Devices as amended by Guidance for Industry - Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software:2005  
SEPT - MED DEVICE CHECKLIST KIT* - *IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - MEDICAL DEVICE SOFTWARE CHECKLIST KIT - INCLUDES; ISO 13485: 2016, IEC 62304: 2015, UL 1998: 2004, ISO/IEC 90003: 2014, ISO 9001: 2015, FDA SW VAL STD CK/L, FDA OTS SW STD CHK/L, FDA MED DEV SW CK/L - SAVE 40% OVER BUYING INDIVIDUAL DOCUMENTS - REPLACES PRODUCT 87; TO PURCHASE CALL 1-800-854-7179 USA/CANADA OR 303-397-7956 WORLDWIDE Organization: SEPT
Date: 2016-03-01
Description: Checklist for Guidance for Industry, FDA Reviewers and Compliance on Off-the Shelf Software Use in Medical Devices as amended by Guidance for Industry - Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software:2005
SEPT - FDA OTS SW STD CK/L - SOFTWARE ENGINEERING PROCESS TECHNOLOGY-EVIDENCE PRODUCT CHECKLIST FOR THE FDA DOCUMENT: “FDA 21 CFR PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES; FINAL RULE” Organization: SEPT
Date: 2012-01-10
Description: Document Number - SEPT FDA INDUSTRY GUIDANCE Software Engineering Process Technology - Evidence Product Checklist for the FDA Document: "Guidance For Industry, FDA Reviewers and Compliance On Off-The-Shelf Software Use In Medical Devices" As Amended By: "Guidance for Industry, FDA Reviewers and Compliance On Cybersecurity for Networked Medical Devices Containing Off-The Shelf (OTS) Software" The experts at SEPT have updated Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices to reflect the suggested compliance with the document Compliance on Cyersecurity for Networked Medical Devices Containing Off-the Shelf (OTS) Software dated January 14, 2005.
DS/IEC/TR 80002-3 - MEDICAL DEVICE SOFTWARE - PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES Organization: DS
Date: 2014-06-23
Description: This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes.
IEC TR 80002-3 - MEDICAL DEVICE SOFTWARE – PART 3: PROCESS REFERENCE MODEL OF MEDICAL DEVICE SOFTWARE LIFE CYCLE PROCESSES (IEC 62304) - EDITION 1.0 Organization: IEC
Date: 2014-06-01
Description: This part of IEC 80002, which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes.
SEPT - IEC 62304 CHECKLIST - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40 Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
SEPT - IEC 62304 CHECKLIST* - * IN EDITABLE MICROSOFT WORD - SOFTWARE ENGINEERING PROCESS TECHNOLOGY - EVIDENCE PRODUCT CHECKLIST FOR STANDARD IEC 62304:2015 “MEDICAL DEVICE SOFTWARESOFTWARE LIFE CYCLE PROCESSES” - REPLACES PRODUCT 40; INCLUDES ACCESS TO ADDITIONAL CONTENT Organization: SEPT
Date: 2015-10-20
Description: Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis.
AAMI TIR45 - GUIDANCE ON THE USE OF AGILE PRACTICES IN THE DEVELOPMENT OF MEDICAL DEVICE SOFTWARE Organization: AAMI
Date: 2012-01-01
Description: It relates them to the following existing standards, regulations, and guidance: • ISO 13485:2003, Quality management systems─Requirements for regulatory purposes • IEC 62304, Medical device software–Software lifecycle processes • ISO 14971:2007, Medical devices─Application of risk management to medical devices • FDA Code of Federal Regulations (CFR), Title 21, Part 820.30, Quality System Regulation: Design Controls–FDA Guidance for the content of premarket submissions for software contained in medical devices • FDA General principles of software validation; Final guidance for industry and FDA staff Although this TIR does not provide a particular perspective for IEC TR 80002-1 (Guidance on the application of ISO 14971 for medical device software), the pertinent aspects of software risk management for medical devices were integrated throughout this TIR.
AAMI TIR36 - VALIDATION OF SOFTWARE FOR REGULATED PROCESSES Organization: AAMI
Date: 2007-01-01
Description: It does not apply to • software used as a component, part, or accessory of a medical device, or • software that is itself a medical device. This TIR may provide useful information and recommendations to • people responsible for determining the appropriate content and size of a validation effort; • people responsible for performing the analyses and evaluations that drive the content or size determination; • people responsible for planning and executing the validation activities; • people responsible for reviewing and approving the adequacy of the validation effort; and • people responsible for auditing, inspecting, and evaluating the validation for compliance to regulation.
AAMI SW87 - APPLICATION OF QUALITY MANAGEMENT SYSTEM CONCEPTS TO MEDICAL DEVICE DATA SYSTEMS - FDA RECOGNIZED Organization: AAMI
Date: 2012-01-01
Description: This document describes the importance of and provides guidance on the implementation of quality management systems to the design, development, provision, and support of medical device data systems as defined by the U.S. Food and Drug Administration (FDA). The FDA quality system regulation documented in 21 CFR 820 defines such a quality management system.

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