Comprehensive Biocompatibility Solutions for Medical Device Manufacturers
Navigate the complexities of ISO 10993, MDR, and FDA compliance with a trusted testing partner. From initial Biological Evaluation Plans (BEP) to final registration support, we ensure your product reaches the market safely and on time.
Why Top MedTech Companies Choose EBI
At EBI, we understand that for medical device manufacturers, testing is not just a checkbox—it’s a critical path to market. We provide a „no-headache” approach to biocompatibility.
- Global Recognition: Our reports are recognized by Competent Authorities and Notified Bodies worldwide (EU MDR & US FDA).
- Zero Hidden Costs: Transparent pricing with comprehensive service packages.
- Expert-to-Expert Communication: Speak directly with toxicologists and specialists, not just sales reps.
- Unmatched Reliability: Over 99% of our reports are delivered on time, helping you avoid costly launch delays.
Our Regulatory & Technical Credentials
- ISO 17025 Accredited (Essential for EU MDR compliance)
- GLP Certified (Good Laboratory Practice for FDA & Global submissions)
- FDA 21 CFR Part 58 Compliant
- ASCA Pilot Program (In progress/Upcoming)
- Member of AMMI: Actively shaping global health policies and standards.
End-to-End Testing Services (ISO 10993)
We manage the entire testing process from A to Z in our high-tech, modern laboratory.
- Biological Evaluation Plan (BEP): Strategy to minimize unnecessary testing and costs.
- In-Vitro & In-Vivo Testing: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Implantation.
- Chemical Characterization: Advanced analytical chemistry (Extractables & Leachables) using FT-IR, UV-VIS, and TOC.
- Biological Evaluation Report (BER/BRA): Final assessment of all data for your Technical Documentation.
Our Proven 12-Step Process
- Initial Contact: Response within 1 business day.
- Info Gathering: Technical call with specialists.
- Detailed Quotation: Transparent, no-hidden-fee quote.
- Acceptance: Simple PO & SSF process.
- Sample Receipt: Secure handling at our facility.
- Test Scheduling: Precise timelines established.
- Study Plan: Formal approval for GLP studies.
- Schedule Notification: You know exactly when to expect results.
- Regular Updates: Bi-weekly progress reports.
- Draft Review: Your chance to provide feedback.
- Finalization: Signed reports delivered upon payment.
- Ongoing Support: Assistance during audits and NB queries.
How We Work
Discovery & Insight
We begin with an in-depth consultation to understand your needs, challenges, and objectives. This helps us define the right strategy and scientific approach for your project.
Design & Development
Our experts translate your vision into actionable plans — combining innovative research, data, and technology to build precise and reliable solutions.
Delivery & Support
We implement the solution with full transparency and ongoing communication. After delivery, we stay involved — supporting you with optimization, updates, and future improvements.
FAQ for Manufacturers
Do you support FDA Submissions?
Yes, our GLP-certified studies and BRA reports are tailored for FDA 510(k) and PMA pathways.
How fast can we start?
We respond to inquiries within 48 hours and offer some of the shortest lead times in the industry.
What if a test fails?
We don’t just send a „fail” result. Our experts provide a detailed analysis and recommendations for the next steps.
Do you support FDA Submissions?
Yes, our GLP-certified studies and BRA reports are tailored for FDA 510(k) and PMA pathways.
How fast can we start?
We respond to inquiries within 48 hours and offer some of the shortest lead times in the industry.
What if a test fails?
We don’t just send a „fail” result. Our experts provide a detailed analysis and recommendations for the next steps.
Contact with us
We’re open to collaboration and research partnerships. Fill out the form — our team will respond as soon as possible.
Location:
Europejski Instytut Biomedyczny sp. z o.o.
ul. Bartycka 63A lok. 6, 00-716 Warszawa
Mail:
contact@ebi.bio
Phone:
+48 22 780 06 32
Get in touch
