(incl. testing plan, biometrics, reports, monitoring)
We support you in the planning of a CE-marking study or market monitoring study (PMCF) with your medical devices. If required, we accompany you closely during the implementation, which also includes applications to ethics committees or authorities. We prepare the statistical testing plan with all the necessary information for the analysis of the endpoints as well as the study plan and all reports. We can also take over or accompany the monitoring of the study. At all times we adhere to the requirements of DIN EN ISO 14155 for conducting clinical trials with medical devices as well as all relevant legal requirements.
Electronic study database
For data collection, pfm medical expert uses virtual questionnaires instead of printed forms. These electronic questionnaires significantly shorten the path of the data from collection in the study centres, through examination by study monitors, to evaluation of the study results.
Our browser-based system (secuTrial®) meets all current requirements with regard to data protection in general and for studies in particular. Access to the input masks is password-protected and thus only accessible to registered users. The data is of course transmitted in encrypted form.
Within the framework of market surveillance, we prepare all clinical plans and reports required by the Medical Devices Regulation, like clinical evaluation or market surveillance reports. We use a checklist to request the necessary information from the client in advance. This includes, for example, the countries in which the medical device is marketed, the sales figures, and the complaint statistics. The literature research and the consultation with national vigilance databases is carried out by our experienced team. We then carry out a benefit-risk assessment and summarise this in the report.
The report language is English or German, as desired.