We are particularly experienced with first-in-man studies and post-market clinical follow-up (PMCF) data collection. We provide full-service CRO activities or separate services as required, including regulatory support and medical writing, data management, clinical operations and safety management.

By means of Clinical Evaluation Plans and Reports we initiate analysis of (pre-)clinical data at all phases in product development, as this process feeds directly into the clinical development strategy and is an integral part of MDR requirements.

Pursuant to the MDR, we provide Legal Representative services for non-EU-based Sponsors who are conducting pre-market clinical investigations. We confirm the availability of the required documentation and will be the addressee for all communications.

We provide a variety of consulting services to comply with Medical Device Regulation (MDR), ISO14155 and ISO13485, etc. This includes Quality Management System implementation & review, personnel training & qualification and regulatory consultancy.