{"id":5424,"date":"2015-04-10T15:46:49","date_gmt":"2015-04-10T13:46:49","guid":{"rendered":"https:\/\/www.gkm-therapieforschung.de\/blog\/portfolio-items\/medical-devices\/"},"modified":"2025-04-08T13:01:31","modified_gmt":"2025-04-08T11:01:31","slug":"medical-devices","status":"publish","type":"avada_portfolio","link":"https:\/\/www.gkm-therapieforschung.de\/en\/blog\/portfolio-items\/medical-devices\/","title":{"rendered":"Medical Devices"},"content":{"rendered":"

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Steadily increasing demands for high quality clinical data and a drastically changing regulatory framework represent major challenges for the medical devices industry in the European Union. You are looking for a reliable and experienced partner, who will flexibly respond to your unique needs and situation?<\/p>\n

Benefit from our\u00a0Medical Device Group\u2019s\u00a0<\/em>experience, know-how and practical recommendations on how to gather and evaluate high-quality clinical data for medical devices. GKM\u2019s Medical Device Group offers regulatory, statistical and medical competence and can support you in any aspects of clinical and post-marketing follow-up studies with medical devices.<\/p>\n

The GKM medical device group offers support regarding the implementation the specific requirements of clinical trials with medical devices of all classes in accordance with national and international regulations.<\/p>\n

Our Team also supports you with the preparation of your documents necessary for the German method assessment according to \u00a7137h SGB V (a necessity for reimbursement of novel, high-risk diagnostic or therapeutic devices and procedures).<\/p>\n

Moreover, the medical device group is your primary point of contact and will help you select exactly those of GKM\u2019s services you need to make your project a success \u2013 not more, not less!<\/p>\n<\/div>

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Medical devices service-portfolio<\/h2><\/div>
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