Biostatistics Services for Medical Device Clinical Investigations

Clinical trials for medical devices require a fundamentally different statistical approach than pharmaceutical trials. ACOMED statistik provides specialized biostatistics consulting for medical device companies aiming for CE marking (MDR) or FDA approval. We assist manufacturers of all risk classes in planning and analyzing clinical investigations. Our services include sample size calculation for medical device trials, the definition of appropriate endpoints, development of the Statistical Analysis Plan (SAP), and the final statistical reporting. Whether you need strategic advice on a complex study design or hands-on statistical programming, our independent expertise ensures your clinical data is analyzed robustly and in full compliance with international regulatory standards.