Our range of services

We are happy to advise you as a manufacturer or importer of medical devices from class I to III ( including active medical devices and implants) in all regulatory matters, whether in quality management or technical documentation.

We prepare a gap analysis for you based on the existing documentation. After that we work with you to develop a strategy for implementing the necessary steps and then review the appliedmeasures with regard to compliance with the requirements.

(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.

We support you in the development and implementation of quality management systems in accordance with DIN EN ISO 13485:2016 and the MDR.

We support you in the preparation of the technical documentation or development record of your medical device in accordance with the requirements of the MDR (STED format).

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.

Data security
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.