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IVD Regulation and Software
November 5 - 7, 2024
Digital Conference8:00AM CST // 9:00AM EST // 2:00PM GMT

Adhiraj Mamak
Senior Manager, Global Quality Strategy & Alliances at Illumina
Speaker

Profile

Adhiraj Mamak has 10+ years of experience in the Medical Devices/IVD industry as a Quality professional. In his career, he has been involved in establishing and maintaining QMS meeting global regulatory requirements including ISO 13485:2016, MDSAP, and IVDR. Most recently he led the successful certification of Illumina’s QMS to IVDR and launching Class C certified and Class A declared IVD products in the EU per IVDR requirements. Adhiraj in his current role as Sr. Manager of Global Quality Strategy and Alliances is establishing practices to ensure Illumina is the preferred IVD Supplier/Partner for NGS and smooth integration of QMS during M&A.

Agenda Sessions

  • Managing Quality: Harmonizing the Quality Management System Regulation (QMSR) with ISO 13485

    14:45
  • Ask the Experts: IVDs

    14:15