Strategic Partnership for Notified Bodies & Regulatory Authorities
Supporting Notified Bodies with high-precision laboratory testing, expert technical consultations, and specialized training programs to enhance the safety and compliance of medical devices.
Why Notified Bodies Partner with EBI
In the complex landscape of MDR and global regulations, Notified Bodies require a laboratory partner that offers more than just raw data. EBI provides the analytical depth and regulatory understanding necessary for confident decision-making.
- Accredited Excellence: Full ISO 17025 accreditation and GLP certification ensure that every test meets the highest global standards for data integrity.
- Technical Defense: We provide robust scientific justifications for testing strategies, making the review process smoother and more transparent.
- Unbiased Expertise: As an independent laboratory with over 20 years of experience, our reports are recognized for their objectivity and precision.
- Policy Impact: As active members of AMMI, we contribute to the evolution of health policies and standards, staying ahead of regulatory shifts.
Comprehensive Testing Services for Regulatory Review
We offer a full suite of biocompatibility and chemical characterization services designed to provide clear, audit-ready evidence for Technical Documentation reviews:
- Biological Evaluation Support: Expert review of BEP/BER documents.
- Advanced Chemical Characterization: High-precision E&L studies (FT-IR, UV-VIS, TOC, ICP-MS) to support Toxicological Risk Assessments.
- Biocompatibility Suite: Complete ISO 10993 testing (In-vitro & In-vivo) conducted in our modern, centralized facility.
Specialized Training for Auditors & Technical Experts
Knowledge sharing is at the core of our mission. EBI provides specialized training programs tailored for Notified Body staff to stay updated on the latest testing methodologies and ISO standards.
- ISO 10993 Series Deep-Dive: Understanding the nuances of the latest standard updates.
- Interpreting Chemical Characterization: How to evaluate E&L reports and Toxicological Risk Assessments.
- In-Vitro vs. In-Vivo Methodologies: Emerging trends in reducing animal testing (3Rs principle) and their regulatory acceptance.
- Custom Workshops: We can design specific technical sessions for your team of auditors.
Conferences & Industry Events
EBI is a frequent contributor to international MedTech conferences. We believe in fostering a community where regulators, laboratories, and manufacturers can exchange insights.
- EBI Annual Webinars: Join our technical sessions on the most challenging aspects of biocompatibility.
- Guest Speaking & Panels: Our experts are available for keynote speeches or panel discussions at Notified Body internal events.
- Scientific Publications: Access our latest whitepapers and research summaries on medical device safety.
Collaborative Framework
- Technical Consultation: Direct access to our laboratory heads for clarification on testing methods.
- Audit Support: We welcome inspections and audits from Notified Bodies to verify our quality systems.
- Educational Exchange: Regular updates on new laboratory capabilities and technological advancements.
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
Is EBI a partner laboratory for specific Notified Bodies?
Yes, we actively cooperate with multiple NBs, providing the necessary laboratory infrastructure for their certification processes.
Can you provide speakers for our internal training days?
Absolutely. Our senior toxicologists and regulatory experts frequently conduct educational sessions for auditing teams.
How do you handle data integrity?
We follow strict GLP and ISO 17025 protocols, with full traceability and secure data management systems.
Is EBI a partner laboratory for specific Notified Bodies?
Yes, we actively cooperate with multiple NBs, providing the necessary laboratory infrastructure for their certification processes.
Can you provide speakers for our internal training days?
Absolutely. Our senior toxicologists and regulatory experts frequently conduct educational sessions for auditing teams.
How do you handle data integrity?
We follow strict GLP and ISO 17025 protocols, with full traceability and secure data management systems.
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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