Adhiraj MamakSenior Manager, Global Quality Strategy & Alliances at IlluminaSpeaker
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
Experiences from Large Manufacturers: Portfolio Management
, 17:00View SessionChairperson’s Opening Remarks: In Vitro Diagnostic Regulations
, 08:30View SessionChairperson’s Afternoon Remarks: In Vitro Diagnostic Regulations
, 14:10View SessionMoving Towards Harmonisation: QMS 13485
, 16:15View SessionIVDR Open Forum: Ask the Experts
, 17:00View Session