According to Regulation (EU) 2017/745 (MDR), the safety and performance of a medical device must be verified by clinical evaluation. In many cases this is possible by means of existing data on a comparable product; however, further clinical data may also be required.
Together with you, we at novineon develop a pragmatic approach appropriate to your medical device, including the clinical evaluation plan, the evaluation according to existing data on a comparable product or a clinical study and the clinical evaluation report. In doing so, we cooperate with our team of consultants consisting of recognized clinical specialists.
The clinical evaluation is closely related to other reports required by regulatory authorities, e.g. the PMCF report (Post-Market Clinical Follow-Up) or the SSCP (Summary of Safety and Clinical Performance). A well planned and coordinated strategy offers you clear advantages in terms of time and effort.
Based on our experience and competence, we develop a customized clinical evaluation for you. Quality and efficiency are important to us in fulfilling regulatory requirements.
Contact your novineon specialist.
Phone: +49 7071 98979 – 124