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EU MDR & IVDR Vigilance Expert Masterclass

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 requirements.

The Masterclass is further down the page, click here to see full Recording!

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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:

100% Free Trial, no creditcard required

PS. There is a unique special offer. Scroll down or click here to read about what you get!

2 Minutes Tutorial Video of Hoodin 360 Surveillance & Vigilance 

2. USE THE CORRECT SOURCE AND USE IT CORRECT

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.

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COMMERCIAL BREAK ;)

Yes, we hope that you will start your trial with Hoodin already today. That is why the comment on the above key takeaway is: Hoodin includes automated surveillance and vigilance on all sources mentioned above. Hoodin also harmonizes that data for proper reporting and lets you know what predicate or similar devices you should include as well!

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.

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Start your trial on Hoodin on the button (Special Spring Offer) below to take advantage of the unique offer!

What you get:
 

  • 14 Day Free Trial: Experience Hoodin without any functional limitations* for free over 14 days. Get surveillance on literature, regulatory standards, and more. Receive vigilance on adverse events and recalls globally.

 

  • Surveillance & Vigilance Expert Review of Your Project: Enjoy a 15-minute video meeting with an expert who will provide a review and offer suggestions on optimizing Hoodin for your unique needs.

 

  • EXTRA! The 7-step Compliance Assurance: Upon activating your Hoodin License, receive a voucher for the 7-step compliance assurance session. Veronika Valdova will validate your project using her 7-step process, ensuring you feel 100% confident for audit submissions or report updates. Sleep tight at night before any audit!

 

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Don't Miss Out—Start Your Free Trial on the button below!

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RECORDING OF THE VIGILANCE MASTERCLASS


Check out the recorded version of the Masterclass where Veronika explores the complexities of the current EUDAMED situation and strategies for searching overseas databases like MAUDE, BFARM, MHRA and many others. Veronika emphasizes the importance of adopting diverse approaches for vigilance searches for effective monitoring and reporting.

During the Master Class she relieves both what is needed to do, what mistakes and risks to avoid and how to reach state of the art vigilance.

Let Hoodin do the hard work and you do the smart work

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+ 2000
life science sources is monitored by Hoodin

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