The European Union’s (EU’s) In Vitro Diagnostic Regulation (IVDR) clearly lays out that manufacturers must demonstrate performance, safety and possible risks/controls of products prior to availability within the European marketplace. With this requirement comes the reinforcement of the four main pillars and systems as described within the regulation:
NAMSA invites you to join us for our upcoming webinar as we focus on how each of these elements are closely interlinked and how manufacturers should strategize and not re-invent the wheel to secure IVDR compliance.
Webinar participants will leave with a better understanding of:
About the Presenter:
|Warren Jameson; Senior Regulatory Consultant-IVD, NAMSA
Warren Jameson has served as a Quality Manager ensuring compliance with relevant legislation (served as a qualified ISO9001:2015 auditor and Data protection Officer (GDPR)), managing quality documentation, risk assessments, risk management, and audits. Warren has experience in reviewing technical files and starting the transition from IVDD to IVDR. He also has over 5 years of experience in Research and Development including development of clinical quality controls for use in IVD machinery. His work covered regulatory documentation such as design initiation, design scope, design history, verification and validation of the project and transfer of product. Warren holds a Ph.D. in Molecular Biology investigating Haematology/Oncology and B.Sc. Hons in Molecular Biosciences with a Diploma in Industrial Studies. He furthered his experience and education by acquiring a certificate as an Internal ISO9001:2015 auditor.
|Alex Laan; Principal Regulatory Consultant – IVD, NAMSA
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.