Comprehensive Global Consulting for Medical Device Innovation
Your partner for international market access. We provide specialized consulting services that go beyond standard requirements, ensuring your devices meet global safety and performance standards.
Beyond the Horizon: Global Market Access
While the EU and USA represent the largest markets, the medical device industry is truly global. Navigating the regulatory landscape in regions like Canada, Australia, Brazil, or the UK requires a partner who understands the nuances of international standards and ISO 10993 implementation.
At EBI, we leverage our in-house GLP labs and deep regulatory expertise to support your expansion into every corner of the world. Our „Other Consulting” services are designed for manufacturers who need more than just a test report—they need a roadmap to global success.
Specialized Global Services
1. International Registration & Market Access
We help you adapt your technical documentation for diverse regulatory jurisdictions:
- UKCA Marking (United Kingdom): Navigating the post-Brexit requirements for the UK market.
- MDSAP Support (Medical Device Single Audit Program): Strategic advice for manufacturers targeting the USA, Canada, Brazil, Japan, and Australia simultaneously.
- Global Biocompatibility Strategies: Ensuring your Biological Evaluation Plan (BEP) is designed to satisfy multiple regulatory bodies at once, saving you time and money.
2. Customized Toxicological Assessments
For unique devices or innovative materials, standard tests may not be enough.
- Custom Toxicology Protocols: Designing specific studies for novel materials where ISO 10993 standards might be insufficient.
- Safety Assessments for Non-Medical Products: We apply our medical-grade expertise to high-end wellness or cosmetic devices that require rigorous safety validation.
3. Post-Market Support & Vigilance
Registration is only the beginning. We support you throughout the product lifecycle.
- Post-Market Clinical Follow-up (PMCF) Consulting: Expert advice on the biological aspects of your post-market surveillance.
- Adverse Event Support: If a biological safety issue is reported, we provide immediate laboratory investigation and expert rationales to address regulatory inquiries.
4. Consulting for Regulatory Partners
We act as the specialized technical arm for general RA/QA Consulting firms.
- We provide the „science-heavy” documentation (BER, Toxicological Risk Assessments) that generalist consultants need to complete their clients’ Technical Files.
Why EBI is the Preferred Global Partner
- Universal Standards: Our ISO 17025 accreditation and GLP certification are recognized by regulatory authorities worldwide.
- Consolidated Project Management: No need to manage multiple labs for different regions. We handle the entire biological safety portfolio in-house.
- 99% On-Time Delivery: Global launches depend on strict timelines. We ensure your documentation is ready when you need it.
- Zero Report Rejections: Our commitment to quality means our data is trusted by Notified Bodies, the FDA, and international health authorities alike.
Who We Serve
- Global Corporations: Looking to harmonize their biological evaluation across multiple international sites.
- Regulatory Affairs (RA) Consultants: Who need a reliable laboratory partner to handle the technical aspects of their clients’ submissions.
- Innovation Hubs & Start-ups: Developing „first-of-its-kind” technologies that require a custom-built regulatory and testing path.
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
Does EBI support registrations in markets outside the EU and USA?
Yes. While we specialize in MDR and FDA, our GLP-compliant data and ISO 10993 expertise are the „gold standard” recognized by health authorities in Canada (Health Canada), Australia (TGA), Brazil (ANVISA), and beyond.
Can you help with UKCA marking?
Absolutely. We stay up-to-date with the evolving UK medical device regulations to ensure your products can continue to be sold in the United Kingdom post-MDR.
What if my device doesn’t fit into a standard ISO 10993 category?
This is where we excel. Our consulting team can design a custom Biological Evaluation Plan that uses a risk-based approach to prove safety, even for unconventional or innovative technologies.
Does EBI support registrations in markets outside the EU and USA?
Yes. While we specialize in MDR and FDA, our GLP-compliant data and ISO 10993 expertise are the „gold standard” recognized by health authorities in Canada (Health Canada), Australia (TGA), Brazil (ANVISA), and beyond.
Can you help with UKCA marking?
Absolutely. We stay up-to-date with the evolving UK medical device regulations to ensure your products can continue to be sold in the United Kingdom post-MDR.
What if my device doesn't fit into a standard ISO 10993 category?
This is where we excel. Our consulting team can design a custom Biological Evaluation Plan that uses a risk-based approach to prove safety, even for unconventional or innovative technologies.
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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