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Software Engineering Process Technology (SEPT)
Software Engineering Process Technology Company, (SEPT) is a firm specializing in meeting the software standards information needs of the professional community, particularly concerning ISO/IEC 12207. SEPT provides standards information via books, checklists, reports, and consulting.Computer Hardware
FDA Audit, Validation & Documentation
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Configuration, Acronyms & Abbreviations in Technical Writing
Price: $6 -
Electronic Signatures; Final Rule-FDA 21CFR Part 11
Price: $167 -
ISO 9001:2015 ''Quality Management Systems - Requirements 2015 Edition''
Price: $330 -
ISO/IEC/IEEE 90003:2018 "Software Engineering: Guidelines for the application of ISO 9001:2015 to computer software"
Price: $167
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Configuration, Acronyms & Abbreviations in Technical Writing
IT and PCI Compliance
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ISO/IEC/IEE Standard 15288:2015-Systems and Software Engineering-System Life Cycle Processes - (Third Edition)
Price: $330 -
Guide to Software Engineering Standards and Specifications 1
Price: $299 -
Guide to Software Engineering Standards and Specifications 2
Price: $30 -
Guide to Software Engineering Standards and Specifications 3
Price: $30
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ISO/IEC/IEE Standard 15288:2015-Systems and Software Engineering-System Life Cycle Processes - (Third Edition)
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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 Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $330 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $330 -
Checklist for Standard ISO/IEC 27002:2013 - Information Security Code of Practice
Price: $399 -
FDA, General Principles of Software Validation Final Guidance for Industry and FDA Staff (Release date January 11, 2002)
Price: $167
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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 Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Manufacturing Engineering
Medical Device and Healthcare Technology
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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 Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Price: $330 -
Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices.
Price: $330 -
ISO 13485:2016 “Medical Devices - Quality Management Systems- Requirements for Regulatory Purposes”
Price: $167 -
Medical Software Checklist Kit
Price: $1549
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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 Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software"
Quality Terminologies & Documentations
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Checklist for Standard ISO 9004:2018
Price: $330
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Checklist for Standard ISO 9004:2018
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