Strategic Consulting for Medical Device Compliance
Navigate the complexities of MDR and FDA regulations with confidence. We don’t just deliver reports – we ensure your product reaches the market.
Why EBI Consulting?
Bridging the Gap Between Laboratory Testing and Regulatory Approval
At the European Biomedical Institute (EBI), we understand that a laboratory report is only a means to an end: your product’s registration. While larger labs often leave you alone with a stack of data, we provide a comprehensive and convenient partnership.
As a GLP-certified and ISO 17025-accredited facility, we combine deep technical expertise with a strategic approach to regulatory affairs (RA) and quality assurance (QA).
- No Subcontracting: We own our in-vivo and in-vitro labs, ensuring 100% control over data integrity.
- Zero-Delay Guarantee: Over 99% of our projects are delivered on time, helping you avoid costly market entry delays.
- End-to-End Support: We stay with you until the product is certified, providing free support during interactions with Notified Bodies or the FDA.
Our Consulting Expertise
Tailored Solutions for QA/RA Managers and R&D Teams
We provide specialized consulting services designed to satisfy the most stringent requirements of MDR (EU) 2017/745 and FDA 21 CFR regulations.
1. Biocompatibility Strategy & Documentation (BEP/BER)
The cornerstone of any medical device submission. We help you define what is necessary and, more importantly, what is not.
- Biological Evaluation Plan (BEP): Strategy development to minimize unnecessary testing and costs.
- Biological Evaluation Report (BER / BRA): Comprehensive expert summaries of all testing data.
- Gap Analysis: Identifying deficiencies in your existing technical files before submission.
2. Regulatory Path & Strategy
Whether you are a start-up or a global corporation like B. Braun or Smith & Nephew, we tailor the strategy to your company size and product risk class.
- Strategic advice for MDR (EU) 2017/745 compliance.
- FDA submission support (510(k), PMA) and ASCA program guidance.
- Literature search and clinical evaluation support.
3. Chemical Characterization & Toxicology
Deep-dive consulting into the chemical safety of your materials.
- Toxicological Risk Assessments: Expert toxicologist opinions on extractables and leachables (E&L).
- Material-Mediated Pyrogenicity & Degradation strategies.
The EBI Advantage: Your Goal is Our Mission
„Our success is measured by your product’s registration, not just the delivery of a test report.”
| Feature | EBI Approach | Industry Standard |
|---|---|---|
| Response Time | Within 48 hours + Video Calls | Weeks of waiting |
| Subcontracting | 0% - All in-house labs | Frequent (loss of control) |
| Post-Report Support | Free consulting for Notified Body queries regarding testing | Extra charges or no support |
| Delivery Speed | >99% On-time delivery | Common backlogs (1–3 months) |
Trusted by Experts in Quality & Regulatory Affairs
We are the partner of choice for Quality Assurance (QA) Managers, Regulatory Affairs (RA) Specialists, and CEOs who cannot afford delays. Our reports have a zero-rejection rate from Notified Bodies and the FDA.
We support:
- Large Enterprises: Managing high-volume portfolios with precision.
- SMEs: Providing the expert „extra hand” for biocompatibility.
- Start-ups: Guiding founders through the „regulatory maze” from day one.
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.
Frequently Asked Questions (FAQ)
Does EBI provide support if a Notified Body questions the report?
Absolutely. If a study fails, we don’t just send a report. We provide expert recommendations on the next steps, material changes, or troubleshooting to get your project back on track.
Can you help us if our study fails?
Absolutely. One of the primary goals of a BEP is to provide a „Rationale for Non-Testing” by using existing chemical data or literature, which is highly encouraged by modern standards to reduce animal use.
Are your consulting services compliant with FDA requirements?
The plan should be reviewed whenever there is a change in the manufacturing process, a change in raw material suppliers, or when new clinical data regarding the material safety becomes available.
Does EBI provide support if a Notified Body questions the report?
Yes. Unlike many labs, we provide free consulting and support during your interactions with regulatory authorities. We defend our data and help you answer technical questions.
Can you help us if our study fails?
Absolutely. If a study fails, we don’t just send a report. We provide expert recommendations on the next steps, material changes, or troubleshooting to get your project back on track.
Are your consulting services compliant with FDA requirements?
Yes, our services are aligned with US FDA 21CFR58 and we are moving towards ASCA accreditation to further streamline your US market entries.
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
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