Webinar: Vigilance Medical Device Guidance Part 1
“Mastering Medical Device Regulations (EU) 2017/745”
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.
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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.