AAMI TIR102 2019
$162.84
AAMI TIR102:2019 – U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems
| Published By | Publication Date | Number of Pages |
| AAMI | 2019 | 146 |
This document provides a mapping of the US FDA 21 CFR requirements to the “regulatory requirements” references in ISO 13485:2016. This mapping is intended to be a tool for US industry to help identify the regulatory requirements from the US medical device regulations to be addressed through an ISO 13485 quality management system.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR102:2019; U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016, Quality management systems |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents |
| 6 | Committee representation |
| 8 | Foreword |
| 9 | Introduction |
| 11 | 1 Scope 2 Using this technical information report |
| 12 | 3 Key considerations 3.1 Definitions 3.2 Training and Competence 3.3 Approvals vs. Signature 3.4 Risk Management/Risk-based |
| 13 | Table 1: QS Regulation and risk-related Preamble comments 3.5 CAPA vs. Improvement Process 3.6 Additional Resources 3.6.1 Modernization of the standard and harmonization with the QSR |
| 15 | Table 2: Comparison from 21 CFR 820 to ISO 13485:2016 |
| 99 | Table 3: ISO 13485:2016 to 21 CFR |
