Empowering MedTech Start-ups to Bridge the Gap from Lab to Market
You focus on innovation; we handle the complex world of biocompatibility and regulatory compliance. Tailored testing paths designed for agile medical device companies.
We Speak "Start-up"
Building a medical device start-up is a marathon. Between securing investors and clinical trials, you shouldn’t have to worry if your testing lab understands your constraints. At EBI, we offer more than just data—we offer a partnership that scales with you.
- Investor-Ready Reports: High-quality, GLP-compliant documentation that builds trust during Due Diligence.
- No Hidden Costs: Fixed-price packages so you can manage your burn rate effectively.
- Expert Mentorship: We don’t just test; we explain why and how to optimize your Biological Evaluation Plan (BEP).
- Speed to Market: >96.6% on-time delivery ensures you meet your project milestones and funding deadlines.
Smart Testing Strategies to Save Time & Capital
We know that for a start-up, every dollar and every day counts. We help you avoid „over-testing” through:
- Early-Stage Consulting: Identify potential biocompatibility risks during the prototype phase before you freeze the design.
- Gap Analysis: We review your existing data to see what can be leveraged, reducing the number of new tests required.
- Risk-Based Approach: Using the latest ISO 10993-1 standards to justify why certain expensive tests might not be necessary for your specific device.
From Prototype to Global Success
Whether you are aiming for CE Mark (MDR) in Europe or 510(k) Clearance (FDA) in the US, our accredited laboratory provides the global gold standard in testing:
- ISO 17025 Accreditation
- GLP Certification
- OECD Recognition
Our "Accelerator" Testing Process
- Discovery Call: We understand your technology and your target markets.
- Strategic BEP: We create a Biological Evaluation Plan that satisfies regulators while being cost-efficient.
- Flexible Execution: We adapt to your prototype availability.
- Continuous Updates: Bi-weekly check-ins with your Dedicated Account Manager.
- Regulatory Support: We stand by you during Notified Body or FDA queries—no extra fees.
Why Investors Love EBI Reports
When VCs look at a MedTech start-up, they look for „Regulatory De-risking”. EBI reports are:
- Universally Accepted: No history of report rejections by major Notified Bodies or the FDA.
- Compliant & Robust: Conducted in state-of-the-art facilities with full traceability.
- Comprehensive: Covering everything from Chemical Characterization to Toxicological Risk Assessment.
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 MedTech Founders
At what stage should we contact EBI?
Ideally, during the late R&D/Prototype stage. Early consulting can save you from using non-biocompatible materials that would require a total redesign later.
Do you help with BEP and BER?
Yes, we provide full documentation support—from the initial Plan (BEP) to the final Evaluation Report (BER).
How long does a full biocompatibility suite take?
Timelines vary, but we provide a detailed schedule upfront and stick to it in 99% of cases.
At what stage should we contact EBI?
According to ISO 10993, the report must be carried out by suitably qualified and experienced persons. Our team at EBI consists of expert assessors specialized in biocompatibility and toxicology.
Do you help with BEP and BER?
Yes, we provide full documentation support—from the initial Plan (BEP) to the final Evaluation Report (BER).
Is a BER required for non-contacting devices?
Timelines vary, but we provide a detailed schedule upfront and stick to it in 99% of cases.
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
