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ASQ - FDA WRLDWID QUAL SYS REQMT - THE FDA AND WORLDWIDE QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR MEDICAL DEVICES - SECOND EDITION Organization: ASQ
Date: 2008-01-01
Description: This second edition also addresses a number of additional topics, such as the incorporation of risk management into the medical device organization's QMS, QMS issues related to combination products, the key process interactions within a QMS, effective presentation of and advocacy for a QMS during FDA inspections and third-party assessments, and future FDA compliance and standards activities.
HIMA - 76-9 - PROPOSED AND FINAL FDA REGULATIONS FOR MEDICAL DEVICES AND DIAGNOSTIC PRODUCTS Organization: HIMA
Date: 1991-01-01
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.
ASQ H0965 - THE FDA AND WORLDWIDE QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR MEDICAL DEVICES Organization: ASQ
ASQ H1332 - THE FDA AND WORLDWIDE QUALITY SYSTEM REQUIREMENTS GUIDEBOOK FOR MEDICAL DEVICES Organization: ASQ
HIMA - 91-6 - MEDICAL DEVICE SUBMISSIONS HANDBOOK: GUIDE TO OBTAINING FDA APPROVAL; SUPPLEMENT 1 Organization: HIMA
Date: 1991-01-01
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 GUIDANCE ON MEDICAL - GUIDANCE ON MEDICAL DEVICE PATIENT LABELING; FINAL GUIDANCE FOR INDUSTRY AND FDA REVIEWERS 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
CRC - FDA REGULATORY AFFAIRS - FDA REGULATORY AFFAIRS - THIRD EDITION Organization: CRC
Date: 2014-02-28
Description: Food and Drug Administration (FDA) and drug, biologic, and medical device development. The book is written in plain English, with an emphasis on easy access to understanding how this Agency operates with respect to the practical aspects of U.S. product approval.
ASQ - CAPA FDA-REG IND - CAPA FOR THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2011-01-01
Description: Medical devices, biopharmaceutical, and traditional drug manufacturing companies devote an important part of their resources to dealing with incidents, investigations, and corrective and preventive actions.
NPFC - DI-TCSP-82040 - RESEARCH AND DEVELOPMENT OF MEDICAL PRODUCTS REGULATED BY THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) Organization: NPFC
Date: 2016-05-03
Description: Use/relationship: This Data Item Description (DID) is published by the U.S Army Medical Research & Materiel Command (USAMRMC) to facilitate the acquisition of technical data to support the research and development of drugs, biologics, medical devices, or some component thereof regulated by the U.S.
ASQ - STATS PROC CNTRL FDA-REG IND - STATISTICAL PROCESS CONTROL FOR THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2013-01-01
Description: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on.
ASQ - QUAL RISK MGT FDA-REG IND - QUALITY RISK MANAGEMENT IN THE FDA-REGULATED INDUSTRY Organization: ASQ
Date: 2012-01-01
Description: Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that "absolute safety" (or zero risk) is not achievable.
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.
HHS - 21 CFR PART 814 - PREMARKET APPROVAL OF MEDICAL DEVICES Organization: HHS
Date: 2016-04-01
Description: (a) This section implements sections 515 and 515A of the act by providing procedures for the premarket approval of medical devices intended for human use. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

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