EU MDR & IVDR Vigilance Expert Masterclass with Veronika Valdova
EU MDR & IVDR Vigilance Expert Masterclass
This page is dedicated to the EU MDR & IVDR Vigilance Expert Masterclass where Veronika Valdova explores the complexities of the current EUDAMED situation and strategies for searching overseas databases like MAUDE, BFARM, MHRA and many others.
Theme: EU MDR & IVDR Vigilance Expert Masterclass
Expert speaker: Veronika Valdova
Further down this page, you'll find a summary, and other useful resources and assets.
If you've ever dealt with VIGILANCE, you know how complex and time-consuming it can be. In the recording of the Masterclass found below, you may witness Veronika Valdova teaching the challenges regarding vigilance for post-market surveillance, including the submission process and compliance with surveillance and vigilance requirement
Key takeaways
1. Apply a systematic approach for vigilance
During the Masterclass, it was highlighted that one of the best things to consider is applying a systematic approach. No matter if you do it manually, semi-manually, or using software such as Hoodin for full automation.
A systematic approach to vigilance for medical devices is vital for maintaining compliance, ensuring patient safety, and driving continuous improvement in the medical device industry. It provides a structured framework for identifying, assessing, and managing risks associated with medical devices, ultimately leading to better outcomes for patients and healthcare providers. See the video at 29:00 for this section.
This is a great chance for you to try out an AI-driven and fully automated tool for surveillance & vigilance.
Feel free to take a look at the tutorial below or sign up for a free 14-day trial of Hoodin here:
2. Use the correct source and use it correctly
During the Masterclass, Veronika teaches about what sources to use to retrieve data that is required for a compliant version of PSUR/PMS reporting.
They are all different, and what is most important to be aware of is how they differ in terms of search and export functionalities. Not being aware of this may put you in a situation where the data retrieved is incorrect and/or very hard to use. See the section in the video at 34:00.
3. Vigilance is not easy. Avoid risks and mistakes
Last but not least: Avoid risks and mistakes! Vigilance, deriving from Latin "vigilare" meaning to stay awake, and they did not refer to RA people working late hours performing vigilance. Being alert and awake require having the processes in place and being aware of risks and mistakes that may happen along the way. At 07:15 in the recording of the Masterclass, you can hear Veronika go through the danger zones of vigilance.
