Join our webinar about EUDAMED and discover about the structure and gradual implementation of the EUDAMED database, what it means for your organization, and how to proactively prepare for new obligations as manufacturer, importer or authorized representative.
What you’ll learn:
- What to expect from the roll-out and timeline of each EUDAMED module
- Reporting requirements and how they apply to different economic operators
- Practical tips to ensure data readiness and maintain compliance
No matter your role in regulatory affairs, quality, or leadership, this session is packed with valuable insights to help you successfully meet EU regulatory expectations!
- Date: May 15th
- Time: 11:00 – 12:00 CET
Speakers:
- Aurélie Flament: Senior QA/RA Consultant for medical devices at Strategiqual, a ProductLife Group company. She brings over 20 years of expertise in quality assurance, regulatory affairs, and vigilance. With a background in microbiology and compliance, Aurélie has held key positions at major companies in the ophthalmology and cardiovascular medical device sectors. She has successfully managed the implementation of quality management systems in accordance with ISO standards, including 13485, MDR 2017/745, and other international regulatory frameworks. Her career encompasses a diverse range of responsibilities, from hands-on microbiological control and supplier quality oversight to strategic leadership in audits, risk management, and regulatory submissions. As a vital liaison with notified bodies and national competent authorities, Aurélie ensures regulatory compliance and the establishment of robust quality systems. She is dedicated to providing practical and compliant solutions to clients throughout the entire product lifecycle
- Vincent Lere: Senior Consultant and Pre-Market Manager at Strategiqual, a ProductLife Group company. He brings over a decade of expertise in quality assurance and regulatory affairs within the medical device industry. Vincent holds dual degrees in biomedical engineering and biomaterials, and he has developed a career that includes leadership roles in both start-ups and established MedTech companies. His experience encompasses strategic guidance on compliance with the EU Medical Device Regulation (EU MDR) and the U.S. Food and Drug Administration (FDA) regulations. He also has hands-on experience managing regulatory submissions, implementing Quality Management Systems (QMS), and overseeing product development from early design through to market access. With a strong background in materials science and engineering, Vincent combines technical knowledge with regulatory insight, enabling manufacturers to successfully navigate pre-market challenges and deliver safe, innovative healthcare solutions.
Register now to secure your spot!
