This phase begins with the preparation, editing or updating of the technical dossier to obtain the CE marking, and relative submission to the NB, including the editing of:
- Clinical evaluation report, according to the MEDDEV and MDCG guidelines,
- Risk analysis, according to ISO 14971,
- Labels and compliance of printed material,
- Preparation of advertising material.
Our clients are supported during all of the process of CE marking, responding to the various requests of the NB also during the phases of audit and post-audit.
Moreover, we provide outsourcing of the as requested and defined in art.15 of Regulations 745/2017 and 746/2017.
Thanks to our collaboration with CRO UNIFARM, we are able to support our clients in the identification and management of the clinical investigation plan for medical devices.