10 am ET, NY / 7 am PDT, California / 4 pm CET, Berlin /
5 pm (UTC +3), Athens & Tel-Aviv / 8.5 pm IST, New Delhi
Overview
Are you ready to enhance your knowledge of the European Database for Medical Devices (EUDAMED) and how it can revolutionize device compliance in the EU market?
Dive deep into the core of EUDAMED during this webinar as we dissect its modular architecture, including key modules such as Actors, UDI/Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Post-Market Surveillance, and Market Surveillance. Discover how these modules reshape regulatory processes and strengthen device oversight across the EU.
Uncover the latest updates on EUDAMED’s implementation timeline and how they may impact your compliance strategy. Explore the pivotal role of the Unique Device Identification (UDI) system in driving traceability, enhancing patient safety, and improving healthcare outcomes under the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR).
Join us for this comprehensive session that offers insights into the current landscape and future projections of EUDAMED. In this exclusive webinar in partnership with Honeywell | Life Sciences, you will gain practical guidance on navigating compliance challenges and leveraging the system for enhanced market surveillance and optimized product lifecycle management.
Don’t miss this opportunity to stay ahead in the evolving world of medical device regulation. Register now to secure your spot at the forefront of industry innovation!
Speakers
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Fabrizio ManiglioIndustry & Business Development Director at HoneywellFabrizio Maniglio is an industry thought leader and Honeywell’s Director of Industry and Business Development. He leverages vast subject matter expertise to drive innovation for the industry and within Sparta Systems, where he continuously monitors the evolution of the everchanging healthcare and life-sciences sectors. He fosters contacts with other industry thought leaders and regulators to collaborate and influence the future of our industry.
He contributed five years as an Expert Solutions Engineer with Sparta Systems, deepening his understanding of quality life cycle management and the life science industries. He was a key differentiator in helping customers achieve their quality management goals.
Before Sparta Systems, he served nine years at a leading European-based Contract Manufacturing Organization (CMO) in the Pharma, Biotech, and Specialty ingredients industry. He served in numerous global quality-related roles, spanning Deviations Management, Head of Audit QA and Compliance, and most recently as QA Manager for Data Integrity and Computer Systems Validation in Switzerland, the UK, and China.
As a result, Fabrizio provides a blend of deep industry, QMS, and cuttingedge technical knowledge and is uniquely placed to advise customers and the industry on the future of quality.
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Zillery A. FortnerIndustry and Business Development DirectorZillery A. Fortner is an eminent thought leader in the life sciences industry who utilizes her extensive subject matter expertise to drive innovation. Currently, she serves as the Industry and Business Development Director at Honeywell, where she acts as the internal voice of customers and provides valuable advice for the future of quality in the industry.
Zillery has been working in the medical device field for 25 years. During this time, she has had various roles such as surgical assistant, quality assurance specialist, regulatory affairs expert, and accreditation professional. Her extensive experience in the industry has given her valuable insights into several aspects of quality, equipping her with the knowledge to drive innovation and help meet regulatory compliance requirements.
Apart from her role at Honeywell, Zillery actively participates in professional organizations such as the American Society for Quality (ASQ), Medical Device Innovation Consortium (MDIC), Regulatory Affairs Professionals Society (RAPS), and the Artificial Intelligence AFTO/RAPS Working Group. She collaborates with these organizations and leaders to shape the future of the life sciences industry.
Zillery’s dedication and passion for the field of life science quality are evident in her work and her contributions to help the industry advance.
Partner
Honeywell
Website
https://www.spartasystems.com/Honeywell brings leading-edge quality management solutions to regulated industries. With TrackWise® and TrackWise Digital®, Honeywell provides enterprise and cloud-based QMS software solutions that help companies go to market faster and deliver the highest standards for product quality, compliance, and customer satisfaction. Honeywell is an innovator in its field, driving smart quality with first-of-its-kind AI-enabled quality solutions. By applying the latest digital technologies, our products simplify the process of quality management and guide customers toward proactive quality. The combination of Sparta Systems and Honeywell brings together Sparta Systems’ quality management leadership with over 100 years of industrial and software expertise from Honeywell. Together, Sparta and Honeywell will shape the future of digital quality and operational excellence for the life sciences industry.
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Who Should Attend:
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- Medical device manufacturers and distributors
- Regulatory affairs professionals in the medical device industry
- Quality assurance and compliance personnel in the medical device sector
- Healthcare professionals involved in the selection and use of medical devices
- Industry consultants and advisors specializing in medical device regulations and quality control
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- Skill Level: Intermediate , Expert
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Topics:
- Modular architecture of EUDAMED
- Actors in EUDAMED
- UDI/Device Registration
- Notified Bodies and Certificates
- Clinical Investigations and Performance Studies
- Vigilance and Post-Market Surveillance
- Market Surveillance
- Updates on EUDAMED's implementation timeline
- Role of Unique Device Identification (UDI) system under MDR and IVDR
- Compliance strategies and actionable insights
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Special event information:
All participants will receive a certificate of attendance.
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