A recent report surveying representatives from the medical device industry across the world found that more than 55% claimed only a basic understanding of how to prepare for MDR compliance. With 9 months left, the time to act is now.
In this webinar, we take a hands-on approach to MDR and discuss 6 essential tasks you need to complete before May 2020. Featuring Dr. Matthias Fink, Clinical Reviewer at TÜV SÜD (1 of 2 MDR notified bodies) and Dona Occhipinti, EU MDR Clinical Evaluation Lead at Hillrom, we will dive into the following topics:
- Renewal of certificates under MDD and choosing devices to keep on the EU market.
- Ensuring you have sufficient data for legacy devices and effective strategies to start clinical investigations if you don’t.
- Preparing for SSCP and PMCF requirements under the MDR.
- Live Q&A with our panel to get answers to your most pressing questions about MDR.
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.Message Presenter
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).Message Presenter
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.Message Presenter
Who Should Attend?
This webinar would appeal to senior professionals within the medical device industry in the areas of:
- Clinical / Medical Affairs
- Clinical Operations
- Regulatory Affairs / Compliance
- Medical Research and Development
- Clinical Data Management
- Medical Device Manufacturing
- Contract Research Organizations
What You Will Learn
Attendees will learn about:
- Steps to prepare for MDR 2020
- Clinical data requirements under the MDR
- Preparation for upcoming Post-market Clinical Follow-up (PMCF) requirements
- Actionable tips to help transition your medical devices under MDR
Castor is a cloud-based data solution for medical device clinical trials. By efficiently capturing, processing, and integrating data from multiple sources on one platform, medical device companies are able to increase study efficiency and reduce time-to-market.
Thousands of medical device, biotech, pharma, and academic researchers around the world are now using Castor to maximize the impact of their study data. Castor also has a team of MDR, IVDR, FDA, GCP, and GDPR experts who help companies streamline their regulatory processes.