{"id":410135,"date":"2024-10-20T05:38:58","date_gmt":"2024-10-20T05:38:58","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-tr-12417-22022-2\/"},"modified":"2024-10-26T10:23:17","modified_gmt":"2024-10-26T10:23:17","slug":"bsi-pd-iso-tr-12417-22022-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-tr-12417-22022-2\/","title":{"rendered":"BSI PD ISO\/TR 12417-2:2022"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 Information on device- and drug-related aspects \u2014 Applicable documents for local guidance
4.1 General
4.2 Australia
4.2.1 General <\/td>\n<\/tr>\n
13<\/td>\n4.2.2 Australia: Managing changes
4.2.3 Australia: Clinical evaluation requirements
4.2.4 Australia: Audit requirements
4.3 Brazil
4.3.1 Brazil: Managing changes <\/td>\n<\/tr>\n
14<\/td>\n4.3.2 Brazil: Clinical evaluation requirements
4.3.3 Brazil: Audit requirements
4.4 Canada
4.4.1 Canada: Managing changes
4.4.2 Canada: Clinical evaluation requirements
4.4.3 Canada: Audit requirements
4.5 European Union (EU)
4.5.1 EU: Managing changes <\/td>\n<\/tr>\n
15<\/td>\n4.5.2 EU: Material inclusion and labelling requirements
4.5.3 EU: Clinical evaluation requirements
4.5.4 EU: Audit requirements
4.6 India
4.6.1 India: Managing changes <\/td>\n<\/tr>\n
16<\/td>\n4.6.2 India: Clinical evaluation requirements
4.6.3 India: Audit requirements
4.7 Japan
4.7.1 Japan: Managing changes
4.7.2 Japan: Clinical evaluation requirements
4.7.3 Japan: Audit requirements
4.8 People’s Republic of China (PRC)
4.8.1 PRC: Managing changes <\/td>\n<\/tr>\n
17<\/td>\n4.8.2 PRC: Clinical evaluation requirements <\/td>\n<\/tr>\n
18<\/td>\n4.8.3 PRC: Audit requirements
4.9 Russia
4.9.1 Russia: Managing changes
4.9.2 Russia: Clinical evaluation requirements
4.9.3 Russia: Audit requirements
4.10 United States of America (USA)
4.10.1 USA: Managing changes <\/td>\n<\/tr>\n
19<\/td>\n4.10.2 USA: Clinical evaluation requirements
4.10.3 USA: Audit requirements <\/td>\n<\/tr>\n
20<\/td>\n5 Managing changes that can impact the DCP
5.1 General
5.2 Change evaluation
5.2.1 Identify changes <\/td>\n<\/tr>\n
21<\/td>\n5.2.2 Risk evaluation
5.2.3 Guidance for change evaluation <\/td>\n<\/tr>\n
22<\/td>\n5.2.4 Pre-market
5.3 Interactions with region-specific regulatory authorities \u2014 Post-commercialization <\/td>\n<\/tr>\n
30<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products – Local regulatory information<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n38<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":410143,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-410135","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/410135","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\/410143"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=410135"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=410135"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=410135"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}