Principal Regulatory Consultant, IVD
NAMSA
Alex Laan currently holds the position of Principal Regulatory Consultant at NAMSA. Until recently, Alex worked as Principal Certification Manager at DEKRA Certification BV, Notified Body, overseeing both IVD’s and Medical Devices compliance and device approvals. Before DEKRA, Alex started a career at KEMA Quality in 2006, covering multiple roles, being qualified for lead auditor for Medical Devices and IVD devices, Device Specialist reviewer in IVD's and Medical Devices, including drug-device combinations. Active member of IVD working group within EU Notified Bodies and TEAM-NB, formerly acting as a direct liaison with EU competent authorities. Previously, Alex worked as a product specialist in immunohematological products and plasma products with Sanquin Blood Transfusion Services, Amsterdam, after which he started his career working as a QA/RA manager for IVD Medical devices at Meddens Diagnostics / IBL Hamburg.
Alex has an education as engineer (Dipl.-Ing) in Bioprocesstechnology and Biochemistry.
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Monday, September 12, 2022
3:30 PM – 4:30 PM MST