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| ANSI/AAMI/ IEC 62366 |
Application of usability engineering to medical devices |
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| ANSI/AAMI/ISO 13485:2003 |
Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (Checklist Available) |
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| ANSI/AAMI/ISO 14971 |
Risk Management - Part 1: Application of Risk Management to Medical Devices |
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| ANSI/UL 1998 |
Software in Programmable Components, Second Edition (Checklist Available) (Free Power Point Presentation on how to implement this standard. |
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| ASTM E1384-07 |
Standard Practice for Content and Structure of the Electronic Health Record (EHR) |
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| ASTM E1578 |
Standard Guide for Laboratory Information Management System |
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FDA Guidance
Document 2 |
Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices. (Checklist Available) |
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FDA Guidance
Document 3 |
Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices. (Checklist Available) |
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FDA Guidance
Document 4 |
General Principles of Software Validation - Final Guidance for Industry and FDA Staff (Checklist Available) |
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| FDA 21 CFR Part 11 |
Electronic Records; Electronic Signatures; Final Rule-FDA , 21CFR Part 11 (Checklist Available) |
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| IEC 60601-1 Ed. 3.0 b |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (Checklist Available-Clause 14) To get a free presentation on “The difference between IEC 60601-1-4 and IEC 60601-1(2005) 3rd edition” |
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| IEC 60601-1-1 |
Medical Electrical Equipment-Part 1: General Requirements for Safety- Collateral Standard: Safety Requirements for Medical Electrical Systems |
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| IEC 60601-1-4 |
Medical Electrical Equipment--Part 1: General Requirements for Safety-4. Collateral Standard: Programmable Electrical Medical Systems (Checklist Available) |
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| IEC 61508-3 |
Functional Safety of Electrical/Electronic/Programmable Electronic Safety-Related Systems - Part 3: Software Requirements |
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| IEC 62304 |
Medical device software - Software life cycle processes (Checklist Available) |
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IEC 80001-1 Ed. 1.0 b:2010 |
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
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| ISO 9001:2008 |
Quality Management Systems - Requirements (Checklist Available) |
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| ISO 14155:2011 |
Clinical investigation of medical devices for human subjects -- Good clinical practice |
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| ISO 26000:2010 |
Guidance on Social Responsibility |
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ISO 31000:2009 |
Risk management - Principles and guidelines |
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| ISO/IEC 12207:2008 |
Systems and software engineering-Software life cycle processes (Checklist Available) |
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| ISO/IEC TR 15026 |
Systems and software engineering - Systems and software assurance - Part 1: Concepts and vocabulary |
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| ISO/IEC 15288:2008 |
Systems and software engineering-System life cycle processes (Checklist Available) (Discounted Combo Set of 12207 and 15288 Standards (save 5%) |
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| ISO/IEC 27002:2005 |
Information Technology - Code of Practice for Information Security Management (Checklist Available) |
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| ISO/IEC 90003 |
Software Engineering. Guidelines for the Application of ISO 9001:2000 to Computer Software (Checklist Available) |
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