• Conformity of the devices in accordance with the QMS.
• Maintain up to date versions of technical documentation and the EU DoC.
• Compliance with PMS obligations [Article 10(9) of IVDR].
• Fulfilment of reporting obligations [Articles 82-86 of IVDR].
• Issuance of statement, Sec 4.1 of Annex XIV of IVDR, of the company's building an investigational device and in context of interventional clinical performance studies involving risks for the subjects.
Hidden
SHAH Viqar Ahmed
• Conformity of the devices in accordance with the QMS.
• Maintain up to date versions of technical documentation and the EU DoC.
• Compliance with PMS obligations [Article 10(9) of IVDR].
• Fulfilment of reporting obligations [Articles 82-86 of IVDR].
• Issuance of statement, Sec 4.1 of Annex XIV of IVDR, of the company's building an investigational device and in context of interventional clinical performance studies involving risks for the subjects.
Hidden
Cartography of Mylab Discovery Solutions Pvt. Ltd.