Warren has been in the industry for 14 years, focused on in vitro diagnostics (IVDs) and companion diagnostics (CDx). He has extensive experience in a variety of roles both in research and industry, including Global IVD Regulatory Operations Manager, R&D Scientist, Project Lead and Quality/Regulatory Affairs Manager. Warren is an expert in performance evaluation, post-market surveillance (PMS), analytical performance, clinical performance, scientific validation, labelling information, regulatory assessment, design dossiers, instructions for use (IFUs) and quality management in compliance to the EU’s In Vitro Diagnostic Regulation (IVDR). Furthermore, he has experience with the U.S. Food and Drug Administration’s (FDA’s) 510(k) and Emergency Use Authorization (EUA) submissions.

Prior to joining NAMSA, Warren worked for Randox Laboratories in the UK as Quality Manager (QM), where he 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 ISO9001:2015, ISO13485:2016, ISO14971:2019, EU’s Global Data Protection Regulation (GDPR) and developing/governance of the Quality Management System (QMS). He also helped develop policy within the company on a large range of issues, including health and safety, data protection, privacy and quality, as well as internal and external auditing. Warren has significant experience in developing IVD assays and quality controls (CE marking) with creation of product scope, verification, validation and design transfer of IVDs.

CORE COMPETENCIES

• QMS and technical documentation for IVD devices in compliance with IVDR, CE Marking and FDA submission (e.g. 510(k) and EUA) for novel, standard and legacy devices
• R&D product development cycle (i.e. scope, feasibility, verification and validation) leading to CE Mark for IVD quality controls and assays
• Creating, evaluating and training on documentation, such as performance evaluation, PMS, analytical performance, clinical performance, scientific validation, labelling, regulatory assessments, design dossiers and IFUs
• Experience in several IVD areas, including clinical biochemistry, haematology, infectious disease, oncology, CDx, lipid, cardiac, immunology and endocrinology
• Developing regulatory and clinical strategies, including regulatory pathways, IVDR transition strategies, Notified Body (NB) selection and engagement and key meetings with test houses and subcontractors
• Auditing against ISO13485:2016, ISO17025:2017 and ISO9001:2015

RECENT PROJECTS

• Preparation of Performance Evaluation Plans (PEPs) and Performance Evaluation Reports (PERs) to support EU IVDR 2017/746 compliance for oncology, infectious disease, microbiology and pregnancy assays
• Literature reviews and gap assessments for molecular diagnostics (MDx) oncology and infectious disease panels to identify and prepare existing data to be leveraged in Technical File preparation for EU IVDR 2017/746 compliance
• IVDR readiness support for Class A, B and C hematology, diabetes and infection (CRP) assays, including In Vitro Diagnostic Directive (IVDD) gap assessments, literature reviews, Technical File compilation, PEPs, PERs—including analytical performance reports, scientific validity reports and clinical performance reports—, generation of General Safety and Performance Requirements (GSPR) and Summary Technical Documentation (STED) and generation of PMS reports, including Post-Market Surveillance Plan (PMSP), Post-Market Performance Follow-Up (PMPFP), Periodic Safety Update Report (PSUR) and Post-Market Surveillance Report (PMSR).