IVD Summit: Strategies & Best Practices for Successful EU Notified Body Outcomes

Alex Laan has been in the IVD and Medical Device industry for 20 years, with 12 years working for a respectable EU Notified Body. 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, Alex qualified for Lead Assessor for Medical Devices and IVD devices, Device Specialist reviewer in IVDs and Medical Devices, including drug-device combinations. In these roles, Alex managed projects with large multinationals (a.o. Boston Scientific, Philips), as well as small start-up companies. He 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 the latter company, 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 US FDA. In addition, Alex followed a post-graduate study in technical management at the Twente University, The Netherlands.

Warren has been in the industry for 7 years with 5 years focused on IVD and companion diagnostics.  Warren’s experience is in the development of Quality Controls for assays such as Clinical Biochemistry, Hematology, Lipid, Cardiac, Immunology, Endocrinology and Pediatric. As project lead, he focused on the full R&D cycle of his developed products from scope, feasibility, verification and validation leading to CE mark.

Prior to joining NAMSA, Warren worked for Randox Laboratories in the UK. With Randox, Warren held a variety of roles from R&D Scientist, Project Lead and Quality/Regulatory Affairs Manager. As QM, Warren was responsible for regulatory compliance in clinical operations for Randox’s public health check branch. This gave Warren significant experience in regulatory compliance with relevant legislation such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, GDPR and developing/governance of the Quality Management System. Furthermore, developing policy within the company on a large range of issues which include Health and Safety, Data protection, Privacy and Quality. Moreover, audit experience both internally and externally such as audits of suppliers.

Warren holds a PhD in Molecular Biology investigating Hematology/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 ISO 9001:2015 auditor.

Marco Kalms offers profound expertise in operational management, commercialization strategies, market access and reimbursement. In 2012, he founded Kalms Consulting, focusing on European Market Access for international medical device, diagnostic, bioscience and Health IT companies.

Marco has more than 25 years of experience in operational, strategic and market access leadership positions in the healthcare industry. As a Sales Manager, Country Manager Germany and Managing Director Europe, he contributed significantly to the growth of American Medical Systems, Inc.

In his role as Managing Director Europe, Marco developed market access strategies to open up new markets in the EMEA regions. It is this mixture of operational business and market access experience that is an essential part of the expertise the Kalms Consulting team offers to support healthcare companies.

Dr. Julia Knorr is responsible to analyze medical device technologies in the context of the German healthcare system to tailor unique market access and reimbursement as well as regulatory strategies according to national or supranational legislation. Her work includes creation of value dossiers and therefore assessment of scientific publications and interaction with medical experts and key players in the self-administration of the German Healthcare System.

She gained extensive expertise in project management in the pharmaceutical industry by leading pan-European post-marketing studies for regulatory compliance helping to understand local requirements influencing transnational large-scale projects.

Her background in biochemistry and biomedical sciences allows her to accompany projects in Medtech ranging from classic medical devices to in-vitro diagnostic medical devices up to highly innovative interface technologies.

She has been involved in the organization and realization of several events and webinars and has been invited as a speaker to give presentations on various topics of the European and German healthcare context e.g. IVDR, MDR and Market Access Germany. Due to changes in legislation and emerging digital health applications her focus on digital transformation of the healthcare landscape increased tremendously with a proven track record of relevant events in the field.

Paul Risborough holds the position of Principal Regulatory Consultant at NAMSA. Until recently, Paul worked as the Global Head of Active Implantable Medical Devices at BSI, Notified Body, overseeing the medical device compliance of Active Implantable Medical Devices. Before becoming a BSI manager, Paul was an Active and Active Implantable Device Technical Specialist, Scheme Manager, and an ISO 13485 auditor. Previously, Paul worked as an electronics design engineer, project leader, and engineering manager involved in designing and manufacturing syringe pumps, large volume pumps; RF, ultrasonic, and gas plasma surgical tools; needle-free injectors, and SpO2 meters.

Paul has an education in Systems Engineering, BEng (Hons).