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OnDemand Webinar with Qmed:
How to Prepare for EU MDR 2020 

In less than one year, the Medical Devices Regulation (MDR) will be fully implemented. As of May 2020, medical device manufacturers that wish to distribute products in the European Union will be required to comply with these new rules. For these organizations, there is a lot to do to prepare in a relatively short time. In this webinar, you’ll learn valuable insight from industry experts and medical device manufacturers on how to be fully prepared for this important regulatory change.

Join Michael Drues, recognized Life Sciences expert; Maite Llacer, Director, EU Vigilance at Edwards Life Sciences; Angeles Sanfrancisco, Manager, EU Vigilance at Edwards Life Sciences, and Kim Wakeman, Life Science Solution Expert ETQ to learn: 

  • Overview of EU MDR regulations timeline and scope
  • Where most organizations stand with their compliance journey today
  • Major areas of the Regulations Annexes
  • EU MDR Product Vigilance   
  • Lessons learned and best practices
  • How organizations can determine their readiness 

 Speakers:

Michael Drues, Ph.D.
Michael Drues, Ph.D., is President of Vascular Sciences, a consulting and training company offering a broad range of services to medical device, pharmaceutical & biotechnology companies including creative regulatory strategy & competitive regulatory intelligence, regulatory submission design, FDA presentation preparation & defense. Dr. Drues received his B.S., M.S., and Ph.D. degrees in Biomedical Engineering from Iowa State University in Ames, Iowa. He has worked for and consulted with leading medical device, pharmaceutical and biotechnology companies ranging in size from start-ups to Fortune 100 companies. He also works on a regular basis for the U.S. Food and Drug Administration (FDA), Health Canada, the US and European Patent Offices, the Centers for Medicare and Medicaid Services (CMS) and other regulatory and governmental agencies around the world.

Maite Llácer, PhD, Director Quality Compliance International, Edwards Lifesciences
Maite Llácer, PhD is a Director Quality Compliance International at Edwards Lifesciences (EW). She has responsibility for post market surveillance and vigilance activities within the international region (EMEAC, LATAM, GCK and SEA) for all EW product lines (Transcatheter Valve Replacement Therapy, Surgical , Critical Care and Transcatheter Mitral and Tricuspid Therapies). She is responsible of the Implementation of the Post Market Surveillance initiatives reporting to VP International Quality. Prior to moving to Quality Maite was since 1996 working in different positions in the Regulatory and Quality departments at Edwards (former Baxter). She is a Pharmacist and has a PhD from Chemist-physics department of the University of Valencia.

Angeles Sanfrancisco, Manager Quality Compliance International, Edwards Lifesciences
Angeles Sanfrancisco, MBA is Manager Quality Compliance International at Edwards Lifesciences (EW). She manages the complaint handling group activity within the Transcatheter Valve Replacement Therapy unit at EW in the International region (EMEAC, LATAM, GCK and SEA). Reporting to Director Quality Compliance International, she assures that applicable procedures related to complaint handling and vigilance are followed by all members in the team and in compliance with applicable regulations. Angeles joined Edwards in 2006, since then she has held different positions in the Finance, Regulatory and Quality departments at Edwards. She has an MBA by Business School, Universidad CEU Cardenal Herrera, Valencia (Spain) and an International MBA by London South Bank University, London (UK).

Kim Wakeman, Solutions Engineer, ETQ
With over 20 years of experience working in the medical device industry, Kim has worked with ETQ for more than 15 years. During her tenure at a medical device manufacturer, Kim worked in multiple roles within the Quality Assurance, Regulatory Affairs and IT organizations. She defined/refined, developed, validated and implemented business solutions to streamline processes that were both cost effective and compliant across multiple business units. Kim directly assisted global management teams in audits conducted by regulatory agencies. Her industry experience has provided her with a valuable understanding of business processes and the best methodology to implement them in the ETQ platform. Kim is currently working for ETQ supporting pre-sales and the ETQ small and medium sized enterprises for life science industries.

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EU MDR 2020 Webinar Replay