EBI - European Biomedical Institute

What EBI - European Biomedical Institute does

EBI - European Biomedical Institute (legally Europejski Instytut Biomedyczny sp. z o.o.) is a Poland-based contract testing laboratory headquartered in Warsaw with laboratory operations in Józefów, near Otwock. Founded as a private limited liability company (KRS 0000938236), the firm employs 23 people and operates GLP-certified, ISO 17025-accredited, and US FDA 21CFR58-compliant facilities that it describes as among the most modern in Europe. EBI is positioned as a sister organization to NABI - North American Biomedical Institute, sharing leadership across the two entities.

The institute generates revenue by providing pre-clinical laboratory testing and consulting services to medical device manufacturers and healthcare/pharmaceutical companies developing drug-device combination products. Its service portfolio is anchored by ISO 10993-series biocompatibility testing (Biological Evaluation Plan, cytotoxicity, sensitization, irritation, genotoxicity, hemocompatibility, implantation, systemic toxicity, biological evaluation reporting), supplemented by extractables and leachables testing with toxicological risk assessment, USP <87>/<88> biological reactivity testing, and adjacent release-testing services including ISO 11607 package validation, accelerated aging per ASTM F1980, reprocessing validation, ISO 11737 microbiology and sterility testing, and OECD 428 dermal penetration. Analytical chemistry is performed using Headspace GC-MS, GC-MS, LC-MS, and ICP-MS instrumentation.

EBI operates a professional-services, quotation-based revenue model with project-level pricing and optional multi-year contracts; turnaround times range from approximately four weeks (Biological Evaluation Plan) to 32 weeks (chronic toxicity), with a fast-track option available. Go-to-market combines direct enterprise field sales, inside sales targeting European markets, consultation calendar booking, and content-led demand generation across LinkedIn, Facebook, Instagram, and YouTube. No customer logos, revenue figures, or institutional funding rounds are disclosed in available source material.

Name

EBI - European Biomedical Institute

Legal name

Europejski Instytut Biomedyczny sp. z o.o.

Website

https://ebi.bio

Company type

Private

Operating status

Operating

Headcount range

11–50 employees

Short description

EBI - European Biomedical Institute is a Poland-based, GLP-certified and ISO 17025-accredited contract laboratory providing ISO 10993 biocompatibility, extractables and leachables, USP, and pre-clinical release-testing services to medical device manufacturers and pharmaceutical companies across European markets.

Ownership category

akta.pro rank

Product category

Medical Device Contract Laboratory Services

NAICS

Testing Laboratories and Services (54138)

SIC

Services-Testing Laboratories (8734)

akta.pro primary industry

Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)

akta.pro secondary industries

Extractables & Leachables / Container-Closure Testing (HLAGADAI), Method Development & Validation (ICH/USP) (HLAGADAB), GLP Toxicology (Repeat-Dose, Acute/Subacute) (HLAGAFAD), Microbiology & Sterility Assurance (Bioburden/Endotoxin/Sterility) (HLAGADAE)

Keywords

• Biocompatibility testing
• Medical device testing
• ISO 10993 testing
• Extractables leachables
• Preclinical laboratory services

Headquarters

HQ city

Warsaw

HQ country

Poland

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Infrastructure, Operations, Technology or R&D, Marketing or Sales, Supply Chain

Revenue model

1. Laboratory Testing Services: Pre-clinical testing and consulting services for medical devices including biocompatibility testing, chemical characterization, microbiology and sterility testing, package validation, and reprocessing validation. Services are provided on a project/quotation basis tailored to specific client needs.
2. Consulting Services: Expert consulting services for medical device biocompatibility evaluation, regulatory compliance, and biological evaluation planning. Includes literature research and internal QMS consultation.

Pricing tiers

Go-to-market motion2 records

Distribution channels3 records

Marketing channels6 records

Core offering

EBI operates its own GLP-certified and ISO 17025-accredited laboratories providing pre-clinical biocompatibility and regulatory testing services for medical device manufacturers. Core offerings include ISO 10993 biological evaluation (covering cytotoxicity, sensitization, irritation, genotoxicity, implantation, hemocompatibility, material-mediated pyrogenicity, systemic toxicity, and chemical characterization), Extractables & Leachables testing with toxicological evaluation, USP <87>/<88> biological reactivity testing, ISO 11607 package validation, accelerated aging, reprocessing validation, ISO 11737 microbiology and sterility testing, OECD Test No. 428 skin absorption studies, and expert regulatory consulting. Services are delivered on a quotation basis with multi-year contracts.

Product overview

European Biomedical Institute (EBI) offers a comprehensive portfolio of pre-clinical testing and consulting services for medical devices through a unified service model. The core offerings include Biocompatibility Testing (the primary service covering the full ISO 10993 biological evaluation series, including individual tests such as Cytotoxicity, Sensitization, Irritation, Genotoxicity, Implantation, Hemocompatibility, Material Mediated Pyrogenicity, Toxicity, Chemical Characterization, EO & ECH Residual Testing, and the associated Biological Evaluation Plan and Biological Evaluation Report); Extractables & Leachables Testing (including Toxicological Evaluation for patient exposure risk assessment); Biological Reactivity USP Testing (covering USP <87> and USP <88>); and Other Services (including ISO 11607 Package Validation, Accelerated Aging, Reprocessing Validation, Microbiology and Sterility Testing ISO 11737, OECD In Vitro Skin Absorption Testing, and Consulting Services). EBI operates its own GLP-certified and ISO 17025-accredited laboratories among the most modern in Europe.

Differentiator

Problem solved

Functional benefit

Products and services

• Biocompatibility Testing (ISO 10993 Biological Evaluation) Full ISO 10993 biological evaluation program for medical device manufacturers needing a single accredited laboratory to plan, execute, and document all required biocompatibility endpoints for EU MDR and FDA submissions.
• Extractables & Leachables Testing Chemical and toxicological analysis of potentially harmful materials administered to a patient from a drug or device, including toxicological evaluation per ISO 10993-17 for pharmaceutical and combination product developers.
• Biological Reactivity USP Testing (USP <87> and USP <88>) United States Pharmacopeia biological reactivity testing for plastics and polymeric materials used in medical devices, providing in vitro cytotoxicity (USP <87>) and in vivo plastics classification and systemic toxicity assessment (USP <88>).
• ISO 11607 Package Validation Packaging validation service for medical device manufacturers demonstrating seal and barrier integrity per ISO 11607.
• Accelerated Aging Testing (ASTM F1980) Accelerated aging study service to determine shelf-life and stability of medical devices and packaging per ASTM F1980.
• Reprocessing Validation Reprocessing validation service for reusable medical devices covering cleaning, disinfection, and sterilization processes per ISO 17664, ISO 14937, and ISO 17665-1.
• Microbiology and Sterility Testing (ISO 11737) Microbiology and sterility testing service per ISO 11737, including bioburden, sterility, and bacteriostasis/fungistasis evaluation for medical device manufacturers.
• In Vitro Skin Absorption and Dermal Penetration Testing (OECD Test No. 428) In vitro skin absorption and dermal penetration study per OECD Test Guideline No. 428, for topical/transdermal medical devices and pharmaceutical products.
• Biocompatibility & Regulatory Consulting Services Expert consulting service for medical device manufacturers covering biocompatibility strategy, regulatory compliance planning, testing program design, literature research, and internal quality management system consultation.

Quantifiable outcome

• Shortest possible lead time in cost-effective manner
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

One partnership is on record.

• Konmex LimitedminorOthersKonmex Limited, based in Chelsea House, Chelsea Street, Nottingham, Nottinghamshire NG7 7HP, Great Britain, is a co-controller of personal data processing alongside EBI. The partnership handles GDPR compliance and data protection matters for the joint website operations. This is a data processing partnership rather than a commercial business partnership.

Scale indicators3 records

Recent moves5 records

Expansion highlights5 records

Broad incumbents

• Intertek (Medical & Pharmaceutical Testing): Intertek operates a global network of accredited medical device, pharmaceutical, and materials testing laboratories covering biocompatibility, sterilization, packaging, and shelf-life/accelerated aging - directly overlapping several of EBI's 'Other Services'.
• WuXi AppTec (Medical Device & Biocompatibility Testing): Large global CRO/CDMO with biocompatibility testing, toxicology, and analytical capabilities serving medical device and combination-product sponsors. Same regulatory positioning (GLP/ISO/FDA) but vastly broader footprint.
• Eurofins Medical Device Services: Eurofins operates one of the largest global networks of ISO 17025 / GLP / FDA-compliant medical device testing laboratories, including biocompatibility, E&L, microbiology, and package validation. Overlaps almost entirely with EBI's menu but with global scale.
• Charles River Laboratories: Global CRO with a substantial medical device and biopharmaceutical safety assessment practice offering biocompatibility testing, toxicology, and analytical services. Overlaps with EBI on the safety/biocompatibility portion of its service portfolio.
• Labcorp / Toxikon (formerly Toxikon): Labcorp acquired Toxikon to offer a dedicated medical device and pharmaceutical biocompatibility/toxicology testing practice. Direct service-line competitor to EBI within Labcorp's much larger diagnostics and CRO platform.

Others

• NABI - North American Biomedical Institute: Sister organization to EBI, run by the same CEO Dr. Damian Matak and CSO Prof. Łukasz Szymański, positioned as the transatlantic twin offering the same ISO 10993 biocompatibility testing menu in the US/Canada market.

Emerging players

• Biocompany (BIOCOMPANION / Biocomp GmbH): Germany-based boutique medical device testing CRO offering GLP biocompatibility testing (ISO 10993) and related services. Comparable niche peer to EBI with regional (DACH) overlap on European medical device testing demand.

Direct peers

• Pacific BioLabs (PacBio): Independent GLP-certified CRO specializing in biocompatibility, toxicology, and analytical testing for medical devices and pharmaceuticals under ISO 10993, USP, and FDA 21 CFR Part 58. Closest analog to EBI in terms of service mix and regulatory positioning.
• Nelson Labs (Sotera Health): Nelson Labs, a Sotera Health company, is the largest dedicated medical device and pharmaceutical testing laboratory network in North America/Europe, offering biocompatibility (ISO 10993), extractables & leachables, microbiology/sterility, and package validation. Direct competitor to EBI on essentially every line of EBI's offer, but at vastly greater scale and geographic reach.
• Acculab Life Sciences: Independent GLP-certified medical device testing laboratory offering ISO 10993 biocompatibility, E&L, analytical chemistry, microbiology, and packaging testing. Closest boutique/specialist analog to EBI among US-based peers.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/channel/UCngWdt2nFdc0Si3lXQdu7Zg
• Facebookfacebook.com/EuropeanBiomedicalInstitute
• LinkedInlinkedin.com/company/europeanbiomedicalinstitute
• Instagraminstagram.com/europeanbiomedicalinstitute

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about EBI - European Biomedical Institute