Medplan Private Limited

•Among additional duties, the main responsibilities are the one mentioned in 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) •Compliance with the Vigilance Reporting obligations (Article 87 to 91)