The workshop “Clinical trials (ISO 14155) of medical devices and PMCF-Studies” provides an overview of the regulatory principles, the relevant standards and applicable guidance documents for clinical trials of medical devices. The training covers comprehensively the planning and conduct of clinical trials in accordance with the applicable standard DIN EN ISO 14155. Currently, the requests increase about the need of clinical trials in the context of the post-market surveillance, ie for the CE marking. Also to that matter, will the workshop provide you with the necessary knowledge of the applicable regulations. After your participation in the event, you will be able to plan and conduct a clinical trial of medical devices and cooperate better with CROs, research institutes and universities.
This workshop is for experts and executives from companies in the medical device industry, which deal with the development, production and approval of medical devices. Specifically addressed are employees from the areas of accreditation, quality management, research & development and the safety representative.
New information about this workshop will be available soon.
In the meantime, our experts will gladly advise you personally. We look forward to your call or your message.