{"id":1251,"date":"2017-09-06T11:03:39","date_gmt":"2017-09-06T11:03:39","guid":{"rendered":"http:\/\/wordpress.p441577.webspaceconfig.de\/ueber-uns\/"},"modified":"2019-11-18T15:59:21","modified_gmt":"2019-11-18T14:59:21","slug":"about","status":"publish","type":"page","link":"https:\/\/www.medsyscon.com\/en\/about\/","title":{"rendered":"About"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row el_class=&#8221;our_about_area&#8221;][vc_column el_class=&#8221;width_100&#8243;][vc_column_text]We are a dynamic team of experts for your device approval and quality matters. We have a diverse academic background and many years of practical experience in the life sciences.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/4&#8243;][vc_column_text]<img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-1249\" src=\"http:\/\/wordpress.p441577.webspaceconfig.de\/wp-content\/uploads\/2018\/01\/reinhard-koehler-medsyscon-1.jpg\" alt=\"MedSysCon GmbH: Reinhard K\u00f6hler\" width=\"200\" height=\"200\" srcset=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2018\/01\/reinhard-koehler-medsyscon-1.jpg 200w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2018\/01\/reinhard-koehler-medsyscon-1-150x150.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/>[\/vc_column_text][\/vc_column][vc_column width=&#8221;3\/4&#8243;][vc_column_text]<\/p>\n<h2>Reinhard K\u00f6hler<\/h2>\n<h4>Founder &amp; GM, Consultant<\/h4>\n<p>[\/vc_column_text][vc_column_text]<strong>Education<br \/>\n<\/strong>University Braunschweig, Diploma in Computer Science.<\/p>\n<p><strong>Core Competencies<\/strong><\/p>\n<ul>\n<li>Over 20 years of corporate experience in medical product development, culminating in a three-year R&amp;D Director role at Stryker CMF &#8211; leading 60 employees distributed around 3 sites in US, Ireland and Germany.<\/li>\n<li>Building high-performing teams\/performance turnarounds<\/li>\n<li>Structuring, staffing, aligning &amp; orchestrating medical device organizations.<\/li>\n<li>Medical device development, project management, quality management and regulatory affairs<\/li>\n<li>Quality Management (ISO 13485, ISO 14971, ISO 62304, MDR, CRF Part 820)<\/li>\n<li>Certified Professional for Medical Software (CPMS)<\/li>\n<li>Certificate: Quality Management Systems &#8211; T\u00dcV S\u00fcd<\/li>\n<li>Certificate: Manager Regulatory Affairs &#8211; TU L\u00fcbeck<\/li>\n<\/ul>\n<p><strong>Working Skills<\/strong><\/p>\n<ul>\n<li>Medical Imaging and Navigation Systems<\/li>\n<li>Coordination of offshore development partners<\/li>\n<li>Development of patient specific implants (class III)<\/li>\n<li>Medical device software development according to IEC 62304<\/li>\n<li>Computer System Validation (CSV)<\/li>\n<li>Software Verification and Validation<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;our_about_area&#8221;][vc_column el_class=&#8221;width_100&#8243;][vc_separator][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/4&#8243;][vc_column_text]<img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1652 size-full\" src=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/thomas-wehner-medsyscon.jpg\" alt=\"\" width=\"200\" height=\"200\" srcset=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/thomas-wehner-medsyscon.jpg 200w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/thomas-wehner-medsyscon-150x150.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/>[\/vc_column_text][\/vc_column][vc_column width=&#8221;3\/4&#8243;][vc_column_text]<\/p>\n<h2>Dr. Thomas Wehner<\/h2>\n<h4>Consultant<\/h4>\n<p>[\/vc_column_text][vc_column_text]<strong>Education<br \/>\n<\/strong>PhD in Physics \u2013 Cologne University<\/p>\n<p><strong>Core Competencies<\/strong><\/p>\n<ul>\n<li>Medical device software development according to IEC 62304<\/li>\n<li>Software Architecture, Verification &amp; Validation<\/li>\n<li>Computer System Validation (CSV)<\/li>\n<li>Project Management<\/li>\n<li>Requirements Engineering<\/li>\n<\/ul>\n<p><strong>Working Skills<\/strong><\/p>\n<ul>\n<li>Test Lead for FDA cleared ordering and tracking system for class III patient specific implants.<\/li>\n<li>Turnkey solution for MES to support design and manufacturing of class III patient-specific implants.<\/li>\n<li>Management of introduction of paperless electronic instructions for use system (eIFU).<\/li>\n<li>Model-driven implementation of pharmaceutical terminology management system.<\/li>\n<li>SCRUM product owner<\/li>\n<li>Roll-Out of a Continuous Integration System.<\/li>\n<li>Certified Project Manager (DIN 69900)<\/li>\n<\/ul>\n<p><strong>Techniques<\/strong><\/p>\n<ul>\n<li>Domain Analysis<\/li>\n<li>Stakeholder View Modeling<\/li>\n<li>Agile Processes<\/li>\n<li>Process-Based Project Management<\/li>\n<li>Model-Centric Software Development<\/li>\n<li>User Story Testing<\/li>\n<li>Continuous Delivery<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row][vc_row el_class=&#8221;our_about_area&#8221;][vc_column el_class=&#8221;width_100&#8243;][vc_separator][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/4&#8243;][vc_column_text]<img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-1654 size-full\" src=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/paul-hiller-medsyscon.jpg\" alt=\"\" width=\"200\" height=\"200\" srcset=\"https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/paul-hiller-medsyscon.jpg 200w, https:\/\/www.medsyscon.com\/wp-content\/uploads\/2019\/05\/paul-hiller-medsyscon-150x150.jpg 150w\" sizes=\"auto, (max-width: 200px) 100vw, 200px\" \/>[\/vc_column_text][\/vc_column][vc_column width=&#8221;3\/4&#8243;][vc_column_text]<\/p>\n<h2>Paul Hiller<\/h2>\n<h4>Consultant<\/h4>\n<p>[\/vc_column_text][vc_column_text]<strong>Education<br \/>\n<\/strong>Diploma in Packaging Technology<br \/>\nM.Sc. Packaging, Design and Marketing<\/p>\n<p><strong>Core Competencies<\/strong><\/p>\n<ul>\n<li>Packaging<\/li>\n<li>Design Control<\/li>\n<li>Cleaning, Disinfection and Sterilization<\/li>\n<li>Biocompatibility &amp; Biological Risk Assessment<\/li>\n<li>Process Validations<\/li>\n<li>Clearance (CE and FDA)<\/li>\n<\/ul>\n<p><strong>Working Skills<\/strong><\/p>\n<ul>\n<li>Design Transfer of Patient Specific Implants (class III)<\/li>\n<li>Transport Validation<\/li>\n<li>Supplier Audits<\/li>\n<li>Risk Assessment of Sterile Implants<\/li>\n<li>Cleaning Strategy for Implants<\/li>\n<li>Process Risk Analyses<\/li>\n<li>Transfer of sterile implants to the contract packager<\/li>\n<li>Implementation of new manufacturing processes for implants and instruments<\/li>\n<\/ul>\n<p><strong>Technologien<\/strong><\/p>\n<ul>\n<li>Cleaning Technology<\/li>\n<li>Cleanroom Technology<\/li>\n<li>Packaging Technology<\/li>\n<li>Pressing and Crimping<\/li>\n<li>Machining Technology<\/li>\n<li>Stereo Lithography<\/li>\n<li>Surface Finishing<\/li>\n<li>Powder Coating<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row el_class=&#8221;our_about_area&#8221;][vc_column el_class=&#8221;width_100&#8243;][vc_column_text]We are a dynamic team of experts for your device approval and quality matters. We have a diverse academic background and many years of practical experience in the life sciences.[\/vc_column_text][\/vc_column][\/vc_row][vc_row][vc_column width=&#8221;1\/4&#8243;][vc_column_text][\/vc_column_text][\/vc_column][vc_column width=&#8221;3\/4&#8243;][vc_column_text] Reinhard K\u00f6hler Founder &amp; GM, Consultant [\/vc_column_text][vc_column_text]Education University Braunschweig, Diploma in Computer Science. Core Competencies Over 20 years of corporate experience<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1251","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>About - MedSysCon Medizintechnik GmbH<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.medsyscon.com\/en\/about\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"About - MedSysCon Medizintechnik GmbH\" \/>\n<meta property=\"og:description\" content=\"[vc_row el_class=&#8221;our_about_area&#8221;][vc_column el_class=&#8221;width_100&#8243;][vc_column_text]We are a dynamic team of experts for your device approval and quality matters. 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