Your Trusted Testing Partner for Regulatory & Quality Consulting
Enhance your consulting services with a laboratory that understands MDR and FDA requirements as well as you do. We provide the technical data and expert reports you need to ensure your clients’ successful registration.
A Seamless Extension of Your Consulting Team
As a consultant, your reputation depends on the quality of the partners you recommend. EBI acts as a seamless extension of your team, providing the laboratory evidence required for your regulatory strategies.
- White-Glove Support: We handle the complex testing, while you maintain the strategic relationship with your client.
- Zero Report Rejections: Protect your reputation with reports that are consistently accepted by Notified Bodies and the FDA.
- Direct Access to Experts: No gatekeepers. Your team gets direct access to our toxicologists and lab specialists to discuss study designs.
- Fast Response Times: We provide quotes within 48 hours, so you can keep your project timelines on track.
Technical Excellence You Can Defend
We provide the „hard data” to support your „soft-tissue” documentation. Our facilities are fully equipped to handle the most demanding testing suites:
- Comprehensive Compliance: ISO 17025, GLP, and FDA 21 CFR 58 compliance.
- Analytical Rigor: State-of-the-art Chemical Characterization (Extractables & Leachables) to support your Toxicological Risk Assessments.
- End-to-End Documentation: From Biological Evaluation Plans (BEP) to final Summary Reports (BER/BRA), we provide documents that are ready for submission.
Why Consultants Prefer EBI
- Reliability (>99% on-time): No more apologizing to your clients for lab delays. We respect your project milestones.
- Regulatory Peace of Mind: We provide ongoing support. If a Notified Body raises questions about our tests, we answer them free of charge as part of your project.
- Proactive Problem Solving: If a study shows adverse results, we don’t just send a fail report. We provide a technical consultation and „next-step” recommendations to help you guide your client.
- No Hidden Costs: Our transparent „all-inclusive” service packages mean no unexpected invoices for your clients.
Partnership Models
We offer flexible ways to work together:
- Referral Partnership: Recommend EBI to your clients, and we’ll provide them with priority onboarding and exceptional service.
- Integrated Partnership: We work as your designated laboratory partner, attending client calls and assisting in the technical defense of the submission.
- Technical Support: Use our lab for specific tests (e.g., Chemical Characterization only) to complement your in-house biological assessments.
Collaborative Process
- Project Review: Send us your client’s device specs and target market.
- Strategic Quote: We provide a detailed, line-item quotation that you can present to your client.
- Active Management: You are kept in the loop with bi-weekly updates from a Dedicated Account Manager.
- Draft Review: You receive draft reports first to ensure they align with your overall regulatory strategy.
- Final Submission: Signed, high-quality reports delivered on time for your filing.
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
Do you subcontract any tests?
No. We have our own in-vivo and in-vitro labs, ensuring full control over quality and timelines.
Can we join the technical calls with our clients?
Absolutely. We encourage collaborative calls to ensure the testing strategy aligns with the regulatory pathway you’ve designed.
Do you offer support for FDA ASCA?
Yes, we are actively implementing the ASCA pilot program requirements to further simplify FDA submissions.
Do you subcontract any tests?
No. We have our own in-vivo and in-vitro labs, ensuring full control over quality and timelines.
Can we join the technical calls with our clients?
Absolutely. We encourage collaborative calls to ensure the testing strategy aligns with the regulatory pathway you’ve designed.
Do you offer support for FDA ASCA?
Yes, we are actively implementing the ASCA pilot program requirements to further simplify FDA submissions.
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
