{"id":2353,"date":"2017-10-15T15:08:16","date_gmt":"2017-10-15T15:08:16","guid":{"rendered":"http:\/\/areton-ltd.com\/?page_id=2353"},"modified":"2017-10-15T15:08:16","modified_gmt":"2017-10-15T15:08:16","slug":"tf-template","status":"publish","type":"page","link":"https:\/\/areton-ltd.com\/es\/tf-template\/","title":{"rendered":"TF Template"},"content":{"rendered":"<p><strong>Guidance:<\/strong><\/p>\n<p><a href=\"http:\/\/areton-ltd.com\/wp-content\/uploads\/2017\/10\/NB-MED-2.5.1-Technical-Documentation.pdf\">NB MED 2.5.1 Technical Documentation<\/a><\/p>\n<p><strong>Guidance Word Format:<\/strong><\/p>\n<p><a href=\"http:\/\/areton-ltd.com\/wp-content\/uploads\/2017\/10\/NB-MED-2.5.1-Technical-Documentation.odt\">NB MED 2.5.1 Technical Documentation<\/a><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Product descrition and summary.<\/strong><\/p>\n<p><strong>Intended use and operation.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Envisaged Manufacturing methods.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>There are two main.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Accessories descriptions.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Device classification.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Applicable directives and standards.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Design Solution to comply with applicable directives and standards.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Evidence of compliance with the standards and directives.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Design risk assements.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Specification of materials and circuit diagram for components subassemblies and the complete product including packaging where appropriate.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>The specifications of the checks, tests and trials that are intended to be carried out as part of routine production.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>The performances and com- patibilities intended by the manufacturer.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Labelling, including any in- structions for use.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Identification of \u2018shelf-life\u2019 re- flected by any \u2018use by\u2019 date, or other \u2018lifetime\u2019 of the device(s).<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Results of Bench Testing.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Clinical Data.<\/strong><\/p>\n<p>&nbsp;<\/p>\n<p><strong>Documentation and reporting of Design Changes.<\/strong><\/p>\n<p><strong> Risk assessments.<\/strong><\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>Guidance: NB MED 2.5.1 Technical Documentation Guidance Word Format: NB MED 2.5.1 Technical Documentation &nbsp; Product descrition and summary. Intended<\/p>","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-2353","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/pages\/2353","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/comments?post=2353"}],"version-history":[{"count":0,"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/pages\/2353\/revisions"}],"wp:attachment":[{"href":"https:\/\/areton-ltd.com\/es\/wp-json\/wp\/v2\/media?parent=2353"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}