{"id":30,"date":"2012-08-24T09:43:54","date_gmt":"2012-08-24T09:43:54","guid":{"rendered":"http:\/\/www.greyra.nl\/?page_id=30"},"modified":"2013-04-14T20:06:05","modified_gmt":"2013-04-14T20:06:05","slug":"services","status":"publish","type":"page","link":"https:\/\/www.greyra.nl\/?page_id=30","title":{"rendered":"Development support"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" alt=\"\" src=\"https:\/\/www.greyra.nl\/wp-content\/uploads\/ProductLifeCycle.png\" width=\"550\" height=\"86\" \/><\/p>\n<p>Examples of Grey RA development support activities in different product life cycle phases.<\/p>\n<h3>Pre-market: Feasibility phase<\/h3>\n<ul>\n<li>Defining a regulatory strategy<\/li>\n<li>Applicable standards selection<\/li>\n<li>Risk management planning and characteristics<\/li>\n<li>Quality system implementation<\/li>\n<li>Quality Management Systems audits and gap analysis<\/li>\n<\/ul>\n<h3>Pre-market: Development phase<\/h3>\n<ul>\n<li>Review of contracts and agreements<\/li>\n<li>Applicable standards deployment<\/li>\n<li>Risk management moderation<\/li>\n<li>Smart Document Control solutions<\/li>\n<li>Quality Management Systems audits and gap analysis<\/li>\n<li>Setting Medical device Software processes<\/li>\n<\/ul>\n<h3>Pre-market: verification &amp; validation phases<\/h3>\n<ul>\n<li>Applicable standard verification<\/li>\n<li>Risk Management reporting<\/li>\n<li>Ensure compliance with Essential Requirements and Essential Principles<\/li>\n<li>Compilation of technical files<\/li>\n<li>Management of submissions<\/li>\n<li>Management of clinical evaluations<\/li>\n<\/ul>\n<h3>Post market<\/h3>\n<ul>\n<li>Support with medical device vigilance<\/li>\n<li>Internal audits<\/li>\n<li>Support with external audits and inspections<\/li>\n<li>Management of re-submissions<\/li>\n<li>Applicable standard monitoring and impact analysis<\/li>\n<li>Management of post market surveillance and post market clinical follow-up<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Examples of Grey RA development support activities in different product life cycle phases. Pre-market: Feasibility phase Defining a regulatory strategy Applicable standards selection Risk management planning and characteristics Quality system implementation Quality Management Systems audits and gap analysis Pre-market: Development &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"more-link\" href=\"https:\/\/www.greyra.nl\/?page_id=30\"> <span class=\"screen-reader-text\">Development support<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"parent":92,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-30","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/pages\/30","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.greyra.nl\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=30"}],"version-history":[{"count":13,"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/pages\/30\/revisions"}],"predecessor-version":[{"id":222,"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/pages\/30\/revisions\/222"}],"up":[{"embeddable":true,"href":"https:\/\/www.greyra.nl\/index.php?rest_route=\/wp\/v2\/pages\/92"}],"wp:attachment":[{"href":"https:\/\/www.greyra.nl\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=30"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}