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?
Benefit from our Medical Device Group’s experience, know-how and practical recommendations on how to gather and evaluate high-quality clinical data for medical devices. GKM’s 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.
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.
Our Team also supports you with the preparation of your documents necessary for the German method assessment according to §137h SGB V (a necessity for reimbursement of novel, high-risk diagnostic or therapeutic devices and procedures).
Moreover, the medical device group is your primary point of contact and will help you select exactly those of GKM’s services you need to make your project a success – not more, not less!
Posts on this topic
Röthler A. Vigilanzsystem Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017
Röthler A. Post Market Surveillance (PMS) Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017
Röthler A. Post Market Clinical Follow-up (PMCF) Experteninhalt, InnovationsLOTSE, www.medizintechnologie.de, 2017
