Full scope Medical Device CRO

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.

Dedicated medical device

Dedicated to all phases of clinical development, including PMCF

Dedicated to clinical data collection that will satisfy the regulator

Dedicated to quality and efficiency

Dedicated teams with short communication lines

New service: PMCF surveys for remote data collection

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:

• Performed fully remotely
• Quick execution
• No ethics review or competent authority approval required
• High quality data can be obtained
• Low cost