The objective of this webinar is to provide manufacturers who intend to market in vitro diagnostic (IVD) products in the European Union (EU) and/or Canada with general guidance on identifying, selecting and approving a designated EU Notified Body, in accordance with the regulatory requirements of the various current Medical Device Directives and the recently published European In Vitro Diagnostic Regulation (IVDR 2017/746).
Topics to be covered during this webinar include:
Time will also be allotted for Q&A.
View the recorded webinar here.
About the Presenter:
Alex Laan, has been in the IVD and Medical Device industry for a total of 20 years with 12 years working for a respectable EU Notified Body. Until recently, Alex held the position of Principal Certification Manager at DEKRA Certification BV, Notified Body for IVDs and Medical Devices located in Arnhem, The Netherlands. After starting at KEMA Quality in 2006, he was qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVD’s and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (e.g., Boston Scientific), as well as small start-up companies. Alex has been an active member of IVD working group within EU Notified Bodies and TEAM-NB and acting as direct contact for EU competent authorities and EMA on implementation of the EU IVDR (2017/746) and EU MDR (2017/745).
Alex has an education as laboratory engineer (BS / Dipl.-Ing) in Bioprocess technology and Biochemistry; University of Teesside, UK. Previously, Alex worked as a product specialist in immune-hematological products and plasma products at Sanquin Blood Transfusion Services, Amsterdam, after which he started his career working as a QA and RA manager for IVD medical devices at Meddens Diagnostics / IBL Hamburg. At Meddens Diagnostics, Alex developed a QMS system from scratch that enabled the company to register a whole range of assays in the EU (Annex II List B) and U.S. FDA. In addition, Alex followed a post-graduate study in technical management at the Twente University, The Netherlands.