Georges HakimDirector RA/QA at Leica Microsystems AG
Medical engineer with more than ten years in the medical devices field and extensive experience in Quality Management and Regulatory Affairs. Passionate leader, interprets the role of Q&R as a strategic business partner and enabler. Solution oriented with a positive can do, will do, must do attitude. Experienced in Medical Device Single Audit Program MDSAP, Corrective Action and Preventive Action CAPA, International registrations, 510(k), Remediation projects, Audit Management as auditee, FDA Inspections, Leading Audits as Auditor, ISO 13485:2016, ISO14971, IEC 60601-1, ISO 10451, STED, MEDDEV 2.7.1 Rev4, Post Market Surveillance PMS, Communication with authorities, Implantable Medical Devices, Animal Tissue, Active Medical Devices, Medical Software, All Classes of Medical Devices.