Omni Lens Pvt Ltd

The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)

The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)

The main responsibilities are the one mentioned on Article 15 of the EU MDR 2017/745. Responsible to ensure :Conformity of the product device to the Medical Device Regulation and quality Management System, Technical Documentation and EU Declaration of conformity, Post-Market Surveillance (PMS) following Article 10(10), the Vigilance Reporting obligations (Article 87 to 91). For investigational devices: lssuance of a signed statement (Annex XV chapter ll section 4.1)