The Medfiles Clinical Team is your perfect partner in planning, coordinating, monitoring and reporting clinical investigations related to medical devices (MD) or post-marketing clinical follow-up studies (PMCFs). As we all know, the European Commission decided to postpone the date of application of the Medical Devices Regulation (MDR) by one year. We now encourage you to use this one-year delay wisely and be prepared with the help of a gap analysis for the upcoming requirements concerning your clinical investigation and evaluation.
The Medfiles Clinical Team has an experienced line-up of medical device-dedicated project managers and CRAs in place. In addition, the Clinical Team works in close collaboration with Medfiles’ medical device regulatory experts, which means that also our regulatory expertise can be smoothly utilised for your MD clinical projects. We are up to date with the ICH E6 (R2) Good clinical practice and the relevant guidance documents related to MD clinical investigations and their evaluation, as provided by the European Commission. In addition, all our MD investigations are governed by dedicated SOPs and we are very familiar with the requirements of the Ethics Committees and the regulatory authorities.
The new ISO 14155 is currently under preparation. Click here to check the latest developments of the standard.