Services, Training & Education
Training & Education
genae's training about clinical research with medical devices is designed for anyone involved in pre- and post-market studies within the medical device industry. Developing medical devices and therapies is a complex and costly matter and can take many years to complete. This course covers all aspects of clinical research activities that are performed during pre- and post-market studies. Please contact us for more information.
The MDD’s main purpose is to harmonize national controls to allow free movement of medical devices throughout the European Union and the European Free Trade Associations while ensuring that all devices within the European Union are reasonably safe to use. genae’s medical device experts assist you in complying with the Medical Device Directive. On request, we will send you our report on obtaining the CE mark and on how we determine your device classification, check all relevant essential requirements, prepare the relevant technical documentation and on how we communicate with the Competent Authorities and Notified Bodies on your behalf.
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