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Tuesday, October 19, 2021

MEDICAL DEVICE NEWS MAGAZINE

A DIGITAL PUBLICATION FOR THE PRACTICING MEDICAL SPECIALIST, INDUSTRY EXECUTIVE AND INVESTOR

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Berlin, Germany | Option to attend virtually
27th – 28th October 2021| 08:30 CET

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 face more stringent requirements fueled by concerns surrounding safety and quality of the products designed and manufactured.  In this era of heightened regulations, companies are reviewing their medical device safety protocols, assessing post-market surveillance strategy, and shoring up internal reporting protocols to achieve global compliance.  Information related to product quality, use, and effectiveness streams in from a variety of sources and companies are accountable to analyze, manage, monitor and report any potential safety related concerns.  It is a challenge to streamline the information and close communications gaps.

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 highest quality and safety of products. The marcus evans EU Medical Device Safety Monitoring and Reporting conference taking place on October 27-28, 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)
  • Optimise 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
  • Create Practices for IVDR
  • Remediate Quality Management Systems (QMS) to resolve Compliance Issues
  • Ensure Traceability 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.

For more information please contact: Ms. Ria Kiayia, Digital Media and PR Marketing Executive at riak@marcusevanscy.com or visit: https://bit.ly/3hShBJc

 

 

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HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

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Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

Alpha Tau Receives FDA’s Breakthrough Device Designation for the RX of Recurrent Glioblastoma Multiforme

"As GBM is such a terrible disease, it is critical that we find new solutions for these patients, and we are thrilled that receipt of the FDA's Breakthrough Device Designation will allow us to expedite our clinical collaborations with leading cancer centers in the U.S. and across the world, and to bring new hope for GBM patients.

FDA Announces Signing of Domestic Mutual Reliance Agreements with California, Florida, Utah and Wisconsin

These Mutual Reliance agreements facilitate a coordinated effort between the FDA and individual states with goals to reduce human foodborne illness outbreaks, reduce duplication of regulatory oversight and increase public health protection by focusing on areas of higher risk.

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