Services
Clinical Research Organization (CRO)
As a Clinical Research Organisation (CRO), we support you in collecting clinical data for your medical device. Our services are modular. You can find an overview of the different modules on the following pages.
Establishing the Clinical Assessment Strategy
We develop a tailored, MDR-compliant clinical evaluation strategy – outlining the possible routes (own clinical data, equivalence data or performance data) – and integrate this into your development process.
Planning and conducting the clinical trial
We support you in the planning, implementation and evaluation of clinical trials – efficiently, in accordance with regulations and practically, from study design to clinical evidence.
Preparation of the Clinical Evaluation
We create complete, audit-proof clinical evaluations including CEP, automated literature search and CER – digitally, consistently and medically and regulatory vetted.