David Tome
David is a recognized expert in clinical research and medical device regulation (MDR/IVDR). He is currently President and former Head of Clinical Operations at MDx CRO, a strategic consulting firm that helps MedTech and IVD companies bring their technologies from patent to market in the EU and the U.S. With over 15 years of experience leading clinical operations at industry giants such as Philips and Olympus, he combines his executive role with teaching as a visiting professor at business schools and universities (ESAME, CEU). He specializes in clinical project management, obtaining CE Marking, and developing clinical evaluation reports (CER/PER).
Latest Articles
Blog & Insights
Clinical Evaluation Plan Template under EU MDR: Structure and Checklist
Last Updated: 2026-08-12
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Blog & Insights
Clinical Investigation Report Template under EU MDR: CIR and Summary Requirements
Last Updated: 2026-07-29
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Regulatory Updates
Real Decreto 192/2023: Medical Device Clinical Investigations in Spain
Last Updated: 2026-07-29
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Blog & Insights
AEMPS Clinical Investigation Submission in Spain: MDR Requirements
Last Updated: 2026-07-29
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Blog & Insights
MDCG 2020-10/1 Rev. 1: Safety Reporting in Medical Device Clinical Investigations
Last Updated: 2026-07-29
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Regulatory Updates
Off-Label Medical Device Use Under EU MDR: How to Assess the Data
Last Updated: 2026-07-28
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Regulatory Updates
New Team NB Position Paper | Best Practice for Submission of EU MDR Technical Documentation
Last Updated: 2026-07-21
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Blog & Insights