Head of IVD Notified Body - Regulatory Services
BSI, Netherlands
Alex Laan currently holds the position of Head of IVD Notified Body at BSI, The Netherlands. He is Alex is an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as a direct liaison with EU competent authorities.
Until recently, Alex worked as Principal Consultant IVD at NAMSA. Previously, Alex has worked as Principal Certification Manager at DEKRA Certification BV, Notified Body, overseeing both IVD’s and Medical Devices compliance and device approvals and occupied multiple roles at KEMA Quality, being qualified for lead auditor for Medical Devices and IVD devices, Device Specialist reviewer in IVD's and Medical Devices, including drug-device combinations. 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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Recent developments in UK regulations for IVDs: implications for EU manufacturers.
Thursday, May 11, 2023
11:45 – 12:45 CEST
Meeting the EU IVDR PMS and PMPF provisions – setting up an effective PMS/PMPF and reporting system
Friday, May 12, 2023
10:45 – 11:45 CEST
Friday, May 12, 2023
12:00 – 13:00 CEST