European Biomedical Institute

11/07/2025

🔬 Why a Risk-Based Approach to Biocompatibility Saves You Time and Money

Is more testing always better? Not when it comes to biocompatibility.
A risk-based approach — as recommended by ISO 10993-1 and MDR — helps manufacturers avoid unnecessary testing, focus resources where risks actually exist, and streamline regulatory submissions.

In our latest article, we explain:
💡 How to build a risk-based biocompatibility strategy
💡 Why chemical characterization is key
💡 How this approach leads to faster market approvals

Learn why smart planning is more powerful than excessive testing.

👉 Read the full article here:

https://ebi.bio/why-a-risk-based-approach-to-biocompatibility-saves-you-time-and-money/

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19/05/2025

What Is a Biological Evaluation Plan (BEP)? | Biocompatibility Testing Explained ?

Curious about how medical devices are evaluated for safety? In just 90 seconds, Wiola breaks down the Biological Evaluation Plan (BEP)—a key part of biocompatibility testing required for MDR and FDA compliance.

Learn:
✅ What a BEP is
✅ Why it evolves with your device
✅ The 6 essential components of every BEP

Whether you're in Regulatory Affairs, Quality Assurance, or Medical Device Development, this quick guide is for you!



https://www.youtube.com/shorts/ZWtCvqfkAGs

Send a message to learn more

13/05/2025

🇧🇪 EBI is heading to Regulatory Affairs Professionals Society (RAPS) Euro Convergence 2025 in Brussels on May 13–16

We’re excited to join one of Europe’s leading regulatory affairs events—bringing together experts, authorities, and innovators to discuss MDR/IVDR, global regulations, and the future of patient-focused healthcare.

Our team—Anna Kuźma and Iwona Pobidyńska—will be there and ready to connect with medical device manufacturers and regulatory professionals.

💬 Attending too? Let’s meet in Brussels!

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23/04/2025

🚀 Time and Cost of Biocompatibility Testing: How to Plan Your Project Budget | https://lnkd.in/dZ_Mnyav

Effective planning for biocompatibility testing is essential for medical device manufacturers looking to stay on track with both compliance and budget. With a clear understanding of regulations like MDR and ISO 10993, you can strategically navigate the testing process while avoiding unnecessary expenses and delays.

👉 Explore how to optimize your biocompatibility testing strategy in our latest blog: https://lnkd.in/dZ_Mnyav

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13/02/2025

Grateful for an Unforgettable Arab Health Exhibition 2025

Now that the dust has settled, we want to take a moment to express our deepest gratitude to the organizers, participants, and everyone who made Arab Health Exhibition 2025 an unforgettable event. 🌟

The experience was nothing short of amazing—filled with inspiring conversations, cutting-edge innovations, and a shared passion for advancing global healthcare. We’re truly honored to have been part of this incredible journey.

A heartfelt thank you to everyone who connected with the EBI and NABI teams. Your enthusiasm and insights inspire us to keep striving for excellence. Until we meet again, Dubai! 🌍

26/07/2024

🟦 Are you NERVOUS, worried about the RESULTS of your chemical analysis tests and if they will be delivered on time❓⏱️

🟦 At EBI, we understand that conducting chemical analysis of medical devices is not only a matter of science, but also a matter of trust.🤝

🟦 HOW we’re redefining quality and safety in testing with❓🛡️

🔍 SAFETY FIRST: We identify and quantify every chemical released from your device to ensure it’s safe.

🔬 TAILORED TECHNIQUES: Leverage the unique strengths of each testing method for the most accurate results.

⏱️ TIME AND RESOURCE SAVER: Our professional sample processing and comprehensive analysis streamline your path to market.

🛡️ THOROUGH EXAMINATION: From volatile organic compounds (GC) to trace metals (ICP), we cover all bases for your device’s safety.

🟦 That is why chemical characterization is a real game-changer in medical devices world.

👉 Dive into the details of our cutting-edge testing services on our website. Got questions❓ We’re here to help❗

🟦 Discover more at EBI 🔗https://ebi.bio/

🟦 Transform your testing experience with precision and excellence. Let’s make safety and efficiency your new standard! 🚀

01/07/2024

🟦 The US Food and Drug Administration (FDA) has released a chemical dataset for use by analytical laboratories to verify their ability to detect potentially non-biocompatible chemicals in medical devices. This initiative aims to facilitate and expedite the biocompatibility testing and review processes for medical devices, according to the agency. 🧪

🟦 „A central tenet of the CDRH biocompatibility evaluation is for sponsors to have the option, for some biocompatibility endpoints, to undertake extraction studies to identify and quantify chemicals released from a device and then to perform a toxicological risk assessment (TRA) to determine if the chemicals pose safety issues in the use of the device,” (...) A successful TRA determination is dependent on the sensitivity of the analytical chemistry method used to detect and quantify chemicals that may be present following extraction from a medical device.” 👨‍🔬

🟦 Source:

👉 https://tiny.pl/dps3w

👉 https://tiny.pl/dps35

17/06/2024

🟦 NEW valuable team MEMBER on board of EBI❗

🟦 Youssef Kammel will focus on developing and nurturing relationships with our customers across Europe, providing insights into our cutting-edge medical devices testing services. 🤝

🟦 Rigorous standards and state-of-the-art testing in biocompatibility, chemical characterization and more help us ensure the highest standards of safety and effectiveness for medical device testing services. With Youssef on board, we are confident that we will strengthen our partnerships and explore new opportunities in the European market. 🇪🇺

🟦 If you have any questions about medical devices testing, Youssef will be happy to share his extensive experience and fresh perspective with you. 💬📱

🟦 Let's welcome Youssef to the team and wish him all the best in his new position! 👏

22/05/2024

🟦 We continue our mission to deliver test results on time, supporting our partners in achieving their business goals and improving the quality of healthcare.

🟦 Our recipe for success❓

🟦 It's:

▪️ a qualified team,
▪️ efficient processes,
▪️ advanced technologies.

🟦 Let's talk - together, we can achieve more❗

20/05/2024

🟦 At EBI, we resonate with Dr. Akra’s emphasis on the necessity of high-quality testing. 💡

🟦 By implementing comprehensive test plans and focusing on the acquisition of reliable data, we strive to support our clients through successful market introductions of their innovative medical solutions. ⚕️

🟦 This dedication to quality and detail is absolutly foundation apart in the critical task of advancing medical technology while safeguarding public health. 👨⚕️👩⚕️

15/05/2024

🟦 Hey, Medical Friends and Innovators❗

🟦 Picture this: a gathering where the most prominent minds in the field of medical technology come together in beautiful Brussels for a summit aimed at making positive changes in healthcare...

🟦 WHY ARE WE SUPPORTING Summit organized by Informa Connect as promotional participant❓

🟦 Because it's a meeting of the best and brightest, showcasing their cutting-edge knowledge in law, the latest regulations, biotechnology, related sciences and more. 💡

🟦 Join a fascinating exchange of ideas about precision, accuracy and intelligent use of the latest achievements in medical technology. Stay up to date on issues that are crucial to your business and the health of patients❗

06/05/2024

🟦 The BTEL Summit organized by Business Conference Facilitation on April 24-26, 2024 was another great opportunity to discuss medical devices❗ 💬

🟦 As sponsors, in our materials we got to showcase our cutting-edge solutions and technologies that drive the evolution i of modern medical devices. 📑

🟦 Big shoutout to the organizers for putting together a stellar event, and kudos to all the attendees. 👏

🟦 And how did you like it, dear participants❓ Have you found something interesting in our materials? Write in comment❗