Clinical studies under MDR: Now is the time to act!
The need for clinical studies can affect your medical device both before the declaration of conformity (pre-CE) and after market placement (post-CE, PMCF). The aim of clinical studies is always to verify the safety and performance of your device by means of clinical data. This applies not only to high-risk and innovative devices without the possibility of comparison.
Added value of a clinical study
You may ask yourself whether clinical studies have always to be extensive and complex. While it is certainly true that studies require time and money, they also offer opportunities and added value, even beyond the fulfillment of regulatory obligations. Clinical studies can, for example, provide ideas for (further) product development, generate scientific marketing statements and increase the level of awareness of a device through publications. Moreover, clinical data serve to fulfill further regulatory requirements and provide essential information for clinical evaluation, reporting (PSUR, PMS report, SSCP) and risk management.
From planning to the final report
For many years, we have been supporting medical device manufacturers in the design and application process, project management as well as monitoring and data management/biostatistics for clinical studies at national and international level. In doing so, we firmly adhere to regulatory requirements and guide you safely, quickly and reliably through the various phases of the study: from the formulation of objectives to the preparation of the final report. Depending on the individual needs, we can also take on additional tasks, thereby helping to avoid errors in planning, execution and data interpretation. Our interdisciplinary team for clinical studies offers support from start to finish.
Contact your novineon specialist.
Phone: +49 7071 98979 - 139