{"id":24076,"date":"2025-09-02T08:22:38","date_gmt":"2025-09-02T06:22:38","guid":{"rendered":"https:\/\/academy.qtec-group.com\/veranstalter\/sonja-neuhofen\/"},"modified":"2025-10-27T16:05:22","modified_gmt":"2025-10-27T15:05:22","slug":"sonja-neuhofen","status":"publish","type":"tribe_organizer","link":"https:\/\/academy.qtec-group.com\/en\/organizer\/sonja-neuhofen\/","title":{"rendered":"Dr. Sonja Neuhofen, Trainerin RA \/ QA"},"content":{"rendered":"<p>Dr. Sonja Neuhofen has been working in the <strong>health science and IVD sector<\/strong> since 1999, with a focus on <strong>Regulatory Affairs and Quality Management<\/strong>. She has supported numerous <strong>IVD development projects<\/strong>, prepared <strong>technical documentation<\/strong>, and guided manufacturers through <strong>conformity assessment procedures<\/strong>. She also established <strong>ISO 13485-compliant QMS<\/strong> for certification.<\/p>\n<p>Since 2016, she has worked as an <strong>independent trainer<\/strong>, supporting <strong>manufacturers<\/strong>, <strong>health institutions<\/strong>, <strong>regulatory authorities<\/strong>, and <strong>Notified Bodies<\/strong> in navigating EU regulations. Her core expertise lies in the <strong>In Vitro Diagnostic Regulation (IVDR 2017\/746)<\/strong>. She offers in-depth training on regulatory obligations for <strong>in-house IVDs<\/strong>, <strong>performance evaluation<\/strong>, and <strong>technical documentation<\/strong>.<\/p>\n<p><strong>What matters most to her as a speaker:<\/strong><br \/>\n<em>&#8220;I aim to share regulatory knowledge in a practical, engaging, and enthusiastic way. My training courses focus on the participants\u2019 questions and specific needs. Open exchange enhances understanding and facilitates structured implementation of regulatory requirements. My goal is to create shared \u2018aha\u2019 moments\u2014with joy in learning.&#8221;<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Dr. Sonja Neuhofen has been working in the health science and IVD sector since 1999, with a focus on Regulatory Affairs and Quality Management. She has supported numerous IVD development [&hellip;]<\/p>\n","protected":false},"author":12,"featured_media":24077,"template":"","meta":{"_acf_changed":false,"_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"0","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"class_list":["post-24076","tribe_organizer","type-tribe_organizer","status-publish","has-post-thumbnail","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/tribe_organizer\/24076","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/tribe_organizer"}],"about":[{"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/types\/tribe_organizer"}],"author":[{"embeddable":true,"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/users\/12"}],"version-history":[{"count":0,"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/tribe_organizer\/24076\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/media\/24077"}],"wp:attachment":[{"href":"https:\/\/academy.qtec-group.com\/en\/wp-json\/wp\/v2\/media?parent=24076"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}