 |
 |
 |
| 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 15026 |
Information technology - System and software integrity levels |
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 |
