{"id":4274,"date":"2017-07-19T09:26:47","date_gmt":"2017-07-19T07:26:47","guid":{"rendered":"http:\/\/www.thema-med.com\/?p=4274\/"},"modified":"2017-07-19T09:26:47","modified_gmt":"2017-07-19T07:26:47","slug":"many-reviews-should-expect-during-the-device-design","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2017\/07\/19\/many-reviews-should-expect-during-the-device-design\/","title":{"rendered":"How many reviews should I expect during the device design ?"},"content":{"rendered":"<p>Quality systems standards do not specify how many reviews I should expect during the device design prior to its conclusion, that is when placing the product on the market. The number depends on the complexity of the product. However, the following points may be assumed:<br \/>\n\u2022 design startup;<br \/>\n\u2022 feasibility analysis results;<br \/>\n\u2022 authorization to realize the first functional prototypes;<br \/>\n\u2022 authorization to realize the advanced prototypes;<br \/>\n\u2022 output data confirmation\/authorization to realize pre-series;<br \/>\n\u2022 clinical validation results\/certification tests results;<br \/>\n\u2022 marketing authorization.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Quality systems standards do not specify how many reviews I should expect during the device design prior to its conclusion, that  [&#8230;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[892,1552],"tags":[],"class_list":["post-4274","post","type-post","status-publish","format-standard","hentry","category-faq-en","category-what-are-the-gmp-requirements-faq-en"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>How many reviews should I expect during the device design ? 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