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

• Webinars
• April 14, 2024

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.

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.

Recent Webinars

Balancing technology investments vs benefit: technology enabled services as a route to rapid ROI

• July 22, 2026

Future Ready Pharmacovigilance: When and Why to Outsource

• February 12, 2026

Digital Transformation for Case Intake: The Future of Pharmacovigilance

• April 11, 2025

Revolutionizing Literature Screening: Challenges & Innovations

• February 19, 2025

Sign up for the latest Literature Screening webinar! Learn about AI automation and more…

• January 10, 2025

HaloPV 6.0: One unique solution for all your PV system needs

• December 10, 2024

PreviousReport: The Dynamics of Drug Safety in Small Pharma, Biotech, and Medical Devices

NextQinecsa releases on-demand webinar on mastering Medical Device regulations