Maximizing Patient Safety and Sustaining Long Term Quality Through Enhanced Device Surveillance while navigating the EU Regulatory Landscape
In recent years the European Union has updated their requirements for Medical Device reporting following the FDA in the United States mainly with the EU Medical Device Regulation. Medical device companies continue to look at new strategies, tools, and technologies to achieve a more comprehensive medical device monitoring and reporting framework to ensure the highest quality and safety of products. The marcus evans EU Medical Device Safety Monitoring and Reporting conference taking place on 26-28 October 2021, in Berlin, Germany and virtually, will bring together leading professionals in regulatory affairs, compliance, post-market surveillance, complaint handling, and in other related roles to address emerging compliance concerns, risk management trends, and product safety measures through a more integrated approach to monitoring and reporting.
Attending This Premier marcus evans Conference Will Enable You to:
- Sustain Compliance with EU MDR after the deadline
- Deal with the Requirements of the EUDAMED database
- Discover how EU MDR changes requirements for Post Market Clinical Follow-up Studies (PMCF)
- Optimize Data and Databases for optimal Post Market and Post Clinic Surveillance and Quality
- Evolve Postmarket Surveillance
- Set up integrated Reporting for Compliance with EU MDR
- CreatePractices for IVDR
- RemediateQuality Management Systems (QMS) to resolve Compliance Issues
- EnsureTraceability between Medical Device Development and Post Market Activities
Best Practices and Case Studies from:
- Nilabh Ranjan, Head of Regulatory Affairs (Medical Devices), AMSilk GmbH
- Pavel Kusnierik, Head of Regulatory Affairs, Contipro a.s.
- Paul Malinovski, Head of QM & RA, Director BU Consulting, Pulmotree Medical GmbH
- Jana Goß, Global Head of Regulatory Affairs, Biotype GmbH
- Andreas Oberleitner, Head of Quality Management & Regulatory Affairs, Platomics GmbH
- Luigi Germanò, Head of R&D and Regulatory Affairs Department, FONA S.r.l.
- Surbhi Gupta, Head Clinical/Regulatory Affairs and IP, Precision Robotics Ltd.