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Software Life Cycle Processes

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Medical Device Standards

SEPT has posted on this page the most popular software Medial Device standards.


ANSI/AAMI HE74-2001	Human Factors Design Process for Medical Devices	More Info
ANSI/AAMI/ISO 13485:2003	Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (Checklist Available)	More Info
ANSI/AAMI/ISO 14971	Risk Management - Part 1: Application of Risk Management to Medical Devices	More Info
ANSI/UL 1998	Software in Programmable Components, Second Edition (Checklist Available) (Free Power Point Presentation on how to implement this standard. See detail at the bottom of this page)	More Info
ASTM E1384-07	Standard Practice for Content and Structure of the Electronic Health Record (EHR)	More Info
ASTM E1578	Standard Guide for Laboratory Information Management System	More Info
FDA Guidance Document 2	Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices. (Checklist Available)	More Info

FDA Guidance Document 3	Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices. (Checklist Available)	More Info

FDA Guidance Document 4	General Principles of Software Validation - Final Guidance for Industry and FDA Staff (Checklist Available)	More Info
FDA 21 CFR Part 11	Electronic Records; Electronic Signatures; Final Rule-FDA , 21CFR Part 11 (Checklist Available)	More Info
IEC 60601-1-1	Medical Electrical Equipment-Part 1: General Requirements for Safety- Collateral Standard: Safety Requirements for Medical Electrical Systems	More Info

IEC 60601-1-4	Medical Electrical Equipment--Part 1: General Requirements for Safety-4. Collateral Standard: Programmable Electrical Medical Systems (Checklist Available)	More Info

IEC 61508-3	Functional Safety of Eelectrical/Eelectronic/Programmable Eelectronic Safety-Related Systems - Part 3: Software Requirements	More Info
IEC 62304	Medical device software - Software life cycle processes (Checklist Available)	More Info
ISO 9001:2008	Quality Management Systems - Requirements (New)(Checklist Available) NEW	More Info
ISO/IEC 12207:2008	Systems and software engineering-Software life cycle processes (Checklist Available)	More Info
ISO/IEC 15288:2008	Systems and software engineering-System life cycle processes (Checklist Available) (Discounted Combo Set of 12207 and 15288 Standards (save 5%)	More Info

ISO/IEC 27002:2005	Information Technology - Code of Practice for Information Security Management (Checklist Available)	More Info
ISO/IEC 90003	Software Engineering. Guidelines for the Application of ISO 9001:2000 to Computer Software (Checklist Available)	More Info