According to Regulation 2017 \/ 745 (MDR), clinical evaluation is an essential part of the conformity assessment procedure for manufacturers of medical devices of all risk classes for successful market access. The clinical evaluation serves as systematic proof that the medical device fulfils basic safety and performance requirements and that undesirable side effects are taken into account and excluded. Thus, it serves as evidence of the justifiability of the benefit-risk ratio. <\/p>\n
Furthermore, the continuous and regular updating of the clinical evaluation after the medical device has been placed on the market is part of the Post Market Clinical Follow-up (PMCF).<\/p>\n<\/div><\/div><\/div><\/div><\/div>
First, the process and product requirements are planned, and a strategy for obtaining clinical data is developed. This data can be obtained from studies identified through a review of the scientific literature and\/or from clinical trials. <\/p>\n<\/div><\/div><\/div><\/div><\/div>
In this context, we work closely with experts from university hospitals and physicians in order to be able to draw on the necessary medical expertise for the clinical evaluation.<\/p>\n<\/div><\/div><\/div><\/div><\/div>
This process is part of the technical documentation, so all steps of the clinical evaluation must be documented in a report. The Clinical Evaluation Scope & Plan (CEP) and the Clinical Evaluation Report (CER) are mandatory documents that are continuously updated throughout the product\u2019s lifecycle based on PMCF data. <\/p>\n<\/div><\/div><\/div><\/div><\/div>
In the area of Post-Market Clinical Follow-up (PMCF), we focus on the precise fulfillment of all regulatory requirements. We support you in systematically collecting data from clinical studies and scientific research. <\/p>\n<\/div><\/div><\/div><\/div><\/div>
We not only ensure that the Clinical Evaluation Scope & Plan (CEP) and Clinical Evaluation Report (CER) are updated promptly, but also that all PMCF data is meticulously documented and analyzed. This is how we help you to ensure the long-term conformity of your medical device and optimize its performance and safety. <\/p>\n<\/div><\/div><\/div><\/div><\/div>