6 Essential Steps to Ensure MDR Compliance Before May 2020 (ft. an expert from a notified body)

Dr. Matthias Fink, MD, Board Certified Orthopedic and Trauma Surgeon, Clinical Reviewer, Clinical Centre of Excellence, TÜV SÜD Product Service GmbH, Munich, Germany

Dr. Matthias Fink is a board-certified orthopedic and trauma surgeon with over 17 years of experience in orthopedic, trauma and reconstructive surgery plus extensive training in cardiovascular and thoracic surgery. He possesses expert knowledge in the field of orthopedic implants and cardiac devices. Dr. Fink has been working as a Clinical Reviewer for the Clinical Centre of Excellence for TÜV SÜD Product Service since 2016 and as the Team Leader for the Ortho and Trauma Team since 2018. He is also a medical expert for the clinical audit team within and outside the European Union. Dr. Fink serves as an investigator and co-investigator in national and international Phase III and IV clinical trials for pharmaceuticals and clinical studies for medical devices and presents at national and international conferences on the clinical requirements and the implementation of the EU MDR.

Dona Occhipinti, MPH, CCRP, EU MDR Clinical Evaluation Lead, HILLROM

Dona Occhipinti has 8+ years of experience as a clinical researcher holding a Master’s Degree in Public Health from George Washington University and the SOCRA certification for clinical research professionals (CCRP). Her fields of research include clinical trials in academia, pharma and medical devices including cardiovascular translation science, Alzheimer’s clinical trials at Johns Hopkins, medical device usability, clinical investigations and post-market clinical follow-up studies. As a Lead Specialist of Clinical Compliance at Hillrom, she manages risk-based approaches to meet EU MDR clinical compliance to prepare for audit readiness (e.g. FDA, MDSAP, and internal audit).

Derk Arts, MD, PhD, Founder & CEO of Castor EDC, Epidemiologist

Dr. Derk Arts has over 10 years of experience in medicine, research and data management. He received his MD from Vrije University in 2011 and his PhD from the University of Amsterdam in 2016. During his MD training, Dr. Arts identified a major problem in medical research. Due to the unavailability of affordable, user-friendly data capture tools, researchers were deviating to non-compliant alternatives that reduced data quality, security and reusability, and greatly increased research data waste.

To solve these issues, he founded Castor, a cloud-based platform that enables medical device companies to reduce time-to-market by efficiently capturing, processing and integrating data from multiple sources on a secure centralized platform. Thousands of medical device, biotech, pharma and academic researchers around the world are now using Castor to maximize the impact of their research data and streamline their regulatory processes.