Nos services
We work together with you to develop the clinical studies and post-market clinical follow-up (PMCF) activities that fit your specific needs. As a medical device dedicated CRO, we know the regulatory requirements and the struggles of medical device manufacturers. We provide practical solutions, fit to budget, especially in areas where there is limited guidance from the regulator. We always ensure GCP (ISO14155) compliance in a practical way.
Sufficient clinical evidence is required to obtain – and keep – market approval for your medical device. Our goal is to help you obtain the quality and amount of data that is needed to satisfy the regulatory requirements.
