European Biomedical Institute
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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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🟦 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
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. 👨⚕️👩⚕️
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Ulica Nałkowskiej 5
Warsaw
05-410
Godziny Otwarcia
| Poniedziałek | 08:00 - 16:00 |
| Wtorek | 08:00 - 16:00 |
| Środa | 08:00 - 16:00 |
| Czwartek | 08:00 - 16:00 |
| Piątek | 08:00 - 16:00 |
