MDR Workshop in Germany

In this two-day interactive training class, you will explore the MDR in depth, learn how to reference the MDR for answers tospecific compliance questions and feel confident about those answers from Emergo's leading MDR expert.

Aug 20, 2019

  • UL International Germany GmbH
    Admiral-Rosendahl-Strasse 9
    63263 Neu-Isenburg (Zeppelinheim)
    Germany

Medical Device Regulation (MDR) Training:

Practical Application for RA Professionals

The deadline to comply with the new Medical Devices Regulation (MDR (EU) 2017/745) is approaching and more device companies are starting to plan and implement their transition strategies. However, maintaining CE marking under the MDR will require ongoing, proactive effort. Internal familiarity with the regulation and how it applies to your device(s) is critical to your success in the post-MDR world.

 

Who  Should Attend

This open training is intended for regulatory affairs staff with basic knowledge of the current Medical Devices Directive and/orActive Implantable Medical Devices Directive. Each training session is capped at 16 participants on a first-come, first-serve basis.

 

AGENDA

The agenda comprises 15 modules that will cover:

  • Scope of the MDR
  • Specific roles of the Economic Operations (manufacturer, authorized representative, importer, distributor)
  • The concept of Eudamed and specific challenges
  • How UDI will work under the MDR Conformity assessment and the role of Notified Bodies
  • Post-market surveillance, Post-market clinical follow-up, and vigilance
  • Clinical evaluation and clinical investigations
  • And MUCH more

PRESENTERS

  • Luana Zerafa has over 10 years of industry experience, working with medical devices and applicable regulations in all classes, including implantable devices, ophthalmic products and medication delivery products. Luana is specialized in Quality Engineering and has extensive knowledge on Quality System implementation and improvement as well as compliance to many international standards. She has deep experience in complaint handling and vigilance primarily in the EU; application of lean Six Sigma methodology to make processes more efficient; leading audits; training peers on quality related topics and dealing with Regulators and Notified Bodies in audit situations as well as FSCAs. As Senior Consultant at Emergo by UL, Luana consults on various Quality and Regulatory Affairs projects in Europe.