Zydus MedTech Pvt.Ltd

To ensure Conformity of the device to the Medical Device Regulation and manufacturer’s QMS prior to release. To ensure Conformity of the Technical documentation and EU Declaration of Conformity (DOC) kept up to date based on the change in the applicable standards. To ensure Compliance with Post-market surveillance following Article 10(10) updating them on the EUDAMED portal. To ensure Compliance with the Vigilance Reporting obligations (Article 87 to 91)