{"id":542484,"date":"2024-11-05T16:57:43","date_gmt":"2024-11-05T16:57:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/din-en-iso-13485\/"},"modified":"2024-11-05T16:57:43","modified_gmt":"2024-11-05T16:57:43","slug":"din-en-iso-13485","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/din\/din-en-iso-13485\/","title":{"rendered":"DIN EN ISO 13485"},"content":{"rendered":"<p>This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e. g. technical support). This International Standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Amendment 11 replaces the European Annexes Z which disclose the relationship between clauses of the standard and the EU Directives by the European Annexes Z which disclose the relationship between clauses of the standard and the EU Regulations on medical devices and in vitro diagnostics respectively.<\/p>\n","protected":false},"excerpt":{"rendered":"<p><b>Medical devices &#8211; Quality management systems &#8211; Requirements for regulatory purposes<\/b><\/p>\n<table style=\"width: 100%\" border=\"0\" cellspacing=\"0\" cellpadding=\"0\">\n<tbody>\n<tr>\n<td>Published By<\/td>\n<td>Publication Date<\/td>\n<td>Number of Pages<\/td>\n<\/tr>\n<tr>\n<td><a href=\"https:\/\/pdfstandards.shop\/product-category\/publishers\/din\/\"><b>DIN<\/b><\/a><\/td>\n<td>2021-12<\/td>\n<td>73<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":542497,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[91,136,2635],"product_tag":[],"class_list":{"0":"post-542484","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-03-100-70","7":"product_cat-11-040-01","8":"product_cat-din","10":"first","11":"instock","12":"sold-individually","13":"shipping-taxable","14":"purchasable","15":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/542484","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\/542497"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=542484"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=542484"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=542484"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}