LTR 108: Databases and automation tools for clinical evaluation

Summary

“It is essential to monitor (literature) and stay ahead of the curve so you are not surprised.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal engages with Veronika Valdova to discuss the complexities of clinical evaluation and documentation requirements under the EU MDR. They explore the challenges faced by manufacturers in compiling necessary documents, the role of automation tools in streamlining processes, and the importance of proactive monitoring in ensuring device safety and effectiveness. Veronika shares insights on various automation tools available in the market and emphasizes the need for proper configuration and understanding of these tools to maximize their benefits. The conversation concludes with key takeaways for practitioners in the field.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:47 Introducing Veronika Valdova

01:54 Understanding EU MDR Documentation Requirements

04:06 Challenges in Clinical Evaluation Documentation

06:32 Databases and Automation Tools for Clinical Evaluation

11:29 An Example Use Case of Literature Search Using a Database

13:53 Business Case for Post-Market Surveillance Using Automated Tools

18:36 A Second Example of a Medical Literature Search Tool

21:00 Emerging AI Tools to Analyze Literature Search for Reporting

23:39 Announcements, Key Takeaways and Closing Comments

If you enjoyed this podcast, consider subscribing to the Let’s Talk Risk! newsletter.

Suggested links:

LTR: Understanding the notified body perspective on clinical evaluation.

LTR: Clinical evaluation is a lifecycle process, not a one-time activity.

ACHIEVE: Post-market surveillance workshop.

Key Takeaways

* The documentation requirements in EU MDR are overwhelming.

* Finding appropriate benchmarks is a big challenge.

* Using automation tools can save a lot of time.

* You need to know how to configure the tools.

* Proactive monitoring is essential to avoid surprises.

* Get your information on equivalent devices in order.

* The purpose of a literature review is crucial.

* Plan accordingly for your documentation needs.

* AI tools for risk management are on the horizon.

* You need a human in the loop to verify AI outputs.

Keywords

Risk management, clinical evaluation, EU MDR, automation tools, medical devices, documentation requirements, post-market surveillance, literature review, regulatory compliance, safety and effectiveness

Select Databases and Automation Tools

* Orca1

* Hoodin

* IQVIA

* MedBoard

* HaloPV

About Veronika Valdova

Veronika Valdova specializes in preparing regulatory submissions for medical devices in the EU, specifically Clinical Evaluation (CER), Post-Market Clinical Follow Up (PMCF) reports and plans, and biocompatibility assessments. She is currently a Managing Partner/Consultant at Atete-Zoe, LLC, serving clients in medical devices, pharmaceuticals and drug-device combination products, both in the US and EU jurisdictions. She holds a DVM in Veterinary Medicine, and several certifications in MedDRA, MDR, Design and Interpretation of Clinical Trials, Epidemiology, Law and Good Clinical Practices.

Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.

Disclaimer

Information and insights presented in this podcast are for educational purposes only, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit naveenagarwalphd.substack.com/subscribe