RESEARCH CENTER BIOFORM, LLC

The main responsibilities are the ones mentioned on Article 15 of the EU MDR 2017/745: Conformity of the product device to the Medical Device Regulation and Quality Management System Conformity of the Technical Documentation and EU Declaration of conformity Compliance with Post-Market Surveillance (PMS) following Article 10(10) For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)

The main responsibilities are the ones mentioned on Article 15 of the EU MDR 2017/745: Compliance with the Vigilance Reporting obligations (Article 87 to 91) For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)