PHASE
CLINICAL EVALUATION
To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place.
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Clinical trials are a keystone during the development and life cycle of your medical device. Compliance with the Medical Device Directive, and in the near future the Medical Device Regulation, is vital to be able to obtain and/or maintain CE-marking.
Due to the COVID-19 pandemic, many clinical investigations other than those aimed at management of the disease have been postponed or suspended. The EU Medical Devices Regulation (MDR) 2017/745 reinforces the rules on clinical evidence. In practice, this means that for many devices currently on the market additional clinical data will have to be generated to enable CE-marking under the MDR.
Clinical investigations are not the only method of clinical data collection. Depending on the clinical data gap that needs to be addressed, post-market clinical follow-up (PMCF) surveys can be a valuable data collection tool. In fact, user surveys (collecting of user feedback) are listed in the MDR as a valid method of post-market clinical data collection.
Benefits of PMCF surveys:
To be able to initiate an activity of clinical data collection, the clinical evaluation needs to be in place.
Read moreThe clinical questions that originate from the clinical evaluation feed into a detailed clinical strategy
Read moreBased on a well-developed clinical strategy, planning of the actual clinical operations is started. Planning involves the set-up of essential documents, allocation of resources and selection of partners.
Read moreOperational excellence is in our DNA. In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is collected
Read moreOur clinical data managers and statisticians analyse the collected clinical datapoints and provide you the results. Our medical writers can help write study reports and publication
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