Webinar: Vigilance Medical Device Guidance Part 1 – Mastering Medical Device Regulations

Webinar: Vigilance Medical Device Guidance Part 1

“Mastering Medical Device Regulations (EU) 2017/745”
In this webinar, you will find an in-depth presentation of medical device regulations, essential for pharmacovigilance professionals seeking mastery in compliance and operational excellence. Veronika will guide participants through key regulatory requirements, integration challenges, and actionable steps for building resilient processes to support combined drug and device portfolios within primarily pharma-focused organizations. By the end of this webinar, attendees will possess the knowledge and tools necessary to navigate the complex EU device vigilance regulatory landscape, appreciate the obligations of individual entities in the device lifecycle compared to medicinal products, understand the conceptual differences in drug and device surveillance requirements, and confidently adapt their department to the change.

Duration: 50 minutes

Addressing practical challenges:

  • Explaining the differences between drugs and device safety surveillance
  • Integrating medical devices into drug safety portfolios
  • Interface between Quality, Vigilance, and Regulatory departments and other entities
  • QPPV vs. PRRC
  • Establishing entity ownership interface agreements


Key takeaways:

  • Understanding the differences between drug and device requirements
  • Importance of continuous education
  • Identifying strategies to embrace and integrate products subject to a different set of regulations.


If you have any questions about our webinar or our services, please feel free to contact us.

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About our expert speaker

Veronika Valdova, DVM, Senior Vigilance Device Consultant, Arete-Zoe, LLC

Veronika Valdova is a multi-disciplined professional in the pharma and medical device sectors, with extensive knowledge of all aspects of the product lifecycle. Veronika has an excellent record preparing clinical documentation for medical devices in the EU, specifically Clinical Evaluation Plans and Reports, Post-market Surveillance Plans, Post-Market Clinical Follow-Up (PMCF), and Biocompatibility assessment reports in compliance with EU MDR 2017/745. Since 2013, Veronika has shifted attention from medicinal products to medical devices. In recent years, Veronika has been focusing on helping device manufacturers in transitioning from MDD to MDR. Veronika’s career spans roles in pharmacovigilance, consultancy, and leadership, offering valuable insights across routine and innovative initiatives.