Webinar: Vigilance Medical Device Guidance Part 2

"Post-marketing safety surveillance of medical devices and DDC products, EU and USA"

Join us for Part 2 of our webinar series on post-marketing safety surveillance, where we dive deeper into the intricate world of medical devices and drug-device combination products. Building upon the foundation set in Part 1, this session explores the reporting essentials and obligations associated with the post-marketing safety surveillance of these products in both the EU and USA markets.

Industry expert Veronika Valdova will guide you through current trends and challenges in the industry, offering valuable insights into best practices and regulatory expectations. Attendees will gain a comprehensive understanding of how to navigate the complexities of safety surveillance and ensure compliance with international standards.

Duration: 50 minutes

Topics discussed:

  • Introduction to drug-device and combination products (DDCs)
  • Types of DDCs in Europe and the US
  • Reporting essentials and obligations
  • Essential procedures to cover
  • Comparison of reporting requirements in the EU vs the US
  • Current trends and/or challenges
  • Best practices
  • Key takeaways
  • Q&A

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

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.

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