{"id":198349,"date":"2024-10-19T12:37:37","date_gmt":"2024-10-19T12:37:37","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/aami-tir102-2019\/"},"modified":"2024-10-25T05:10:41","modified_gmt":"2024-10-25T05:10:41","slug":"aami-tir102-2019","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/aami\/aami-tir102-2019\/","title":{"rendered":"AAMI TIR102 2019"},"content":{"rendered":"

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.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\nAAMI TIR102:2019; U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016,
\nQuality management systems <\/td>\n<\/tr>\n
3<\/td>\nTitle page <\/td>\n<\/tr>\n
4<\/td>\nAAMI Technical Information Report
Copyright information <\/td>\n<\/tr>\n
5<\/td>\nContents <\/td>\n<\/tr>\n
6<\/td>\nCommittee representation <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Using this technical information report <\/td>\n<\/tr>\n
12<\/td>\n3 Key considerations
3.1 Definitions
3.2 Training and Competence
3.3 Approvals vs. Signature
3.4 Risk Management\/Risk-based <\/td>\n<\/tr>\n
13<\/td>\nTable 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 <\/td>\n<\/tr>\n
15<\/td>\nTable 2: Comparison from 21 CFR 820 to ISO 13485:2016 <\/td>\n<\/tr>\n
99<\/td>\nTable 3: ISO 13485:2016 to 21 CFR <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

AAMI TIR102:2019 – U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
AAMI<\/b><\/a><\/td>\n2019<\/td>\n146<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":198357,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2654],"product_tag":[],"class_list":{"0":"post-198349","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-aami","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/198349","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/198357"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=198349"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=198349"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=198349"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}