Eurofins Medical Device Testing
★★★★★
2.8
/ 5
•
10,154 reviews
Eurofins Medical Device Testing offers comprehensive testing and certification services for medical devices. They ensure product safety, efficacy, and compliance with global regulatory standards.
Eurofins Medical Device Testing is a global leader providing extensive testing, inspection, and certification services for the medical device industry. With a vast network of over 950 laboratories across 60 countries and more than 65,000 employees, they offer expertise in biocompatibility testing, chemical, physical, mechanical, clinical, environmental, and electrical safety testing. Their services are designed to help manufacturers navigate complex regulatory landscapes, including REACH and other global standards, ensuring products meet stringent quality and safety requirements before market entry. Eurofins supports the entire product lifecycle, from raw materials to finished goods, providing technical compliance files and facilitating access to global markets. They are committed to ensuring human health and environmental safety through rigorous testing and consulting, making them a trusted partner for medical device companies worldwide seeking to achieve compliance and market success.
About
**Who they are**
Eurofins Medical Device Testing is a global provider of testing and certification services for medical devices, ensuring product safety, efficacy, and compliance with international regulatory standards. They offer a broad spectrum of services to support manufacturers in navigating complex compliance landscapes.
**Expertise & scope**
* Comprehensive testing and certification for medical devices.
* Services designed to ensure product safety and efficacy.
* Support for compliance with global regulatory standards.
* Expertise in chemical, physical, mechanical, clinical, environmental, and electrical safety testing.
* Assistance with regulatory programs and Technical Compliance Files to facilitate market access.
**Reputation / proof points**
* Global presence with laboratories worldwide, accessible via an interactive map and group directory.
* Offers services across a vast range of consumer products, indicating broad industry experience.
Eurofins Medical Device Testing is a global provider of testing and certification services for medical devices, ensuring product safety, efficacy, and compliance with international regulatory standards. They offer a broad spectrum of services to support manufacturers in navigating complex compliance landscapes.
**Expertise & scope**
* Comprehensive testing and certification for medical devices.
* Services designed to ensure product safety and efficacy.
* Support for compliance with global regulatory standards.
* Expertise in chemical, physical, mechanical, clinical, environmental, and electrical safety testing.
* Assistance with regulatory programs and Technical Compliance Files to facilitate market access.
**Reputation / proof points**
* Global presence with laboratories worldwide, accessible via an interactive map and group directory.
* Offers services across a vast range of consumer products, indicating broad industry experience.
Additional information
Eurofins Medical Device Testing supports manufacturers in achieving global market access through comprehensive testing and certification. Their services encompass a wide array of testing disciplines, including chemical, physical, mechanical, clinical, environmental, and electrical safety. They assist in developing Technical Compliance Files and navigating regulatory programs. Buyers can leverage their global network of laboratories to ensure their medical devices meet the stringent safety and efficacy requirements mandated by international standards. Engagement typically involves detailed project scoping to address specific device types and target markets.
Key Highlights
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Offers comprehensive testing and certification services for medical devices.
Source
“Eurofins companies' scope of product certifications and third-party approvals for a vast range of consumer products…”
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Ensures product safety, efficacy, and compliance with global regulatory standards.
Source
“They ensure product safety, efficacy, and compliance with global regulatory standards.”
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Provides support for regulatory programs and Technical Compliance Files.
Source
“Regulatory programs, Technical Compliance Files and more to help your products access global markets.”
Certifications & Trust Signals
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Global presence with laboratories worldwide.
Source
“Please click and drag your mouse over the map canvas to navigate and find laboratories.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance.
- Companies requiring comprehensive testing for product safety and efficacy.
How engagement typically works
- Project-based testing and certification.
- Consultative support for regulatory documentation.
Typical deliverables
- Testing reports and certificates.
- Technical Compliance Files support.
- Regulatory compliance assessments.
Good to know
- Best when specific testing protocols and target markets are clearly defined.
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Canada, Australia, Brazil, Europe, Asia
Industries:
Medical Devices
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, Pyrogenicity, Biodegradation
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Eurofins Medical Device Testing offers a comprehensive suite of biocompatibility testing services, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, pyrogenicity, carcinogenicity, reproductive toxicity, biodegradation, and pharmacokinetics. They also support ISO 10993 standards and GLP compliance.
Regions Served:
Czech Republic, Netherlands, New Zealand, Philippines, Switzerland, United Kingdom, UNITED ARAB EMIRATES, United States
Is Accredited:
Yes
Accreditation Body:
ISO 17025
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Sample Return Policy:
Both options
packaging_shelf_life_testing
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18, USP <87>, USP <88>
Test Types Offered
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks, Start in 2-4 weeks, Start in 4-8 weeks, Start in 8-12 weeks, Start in 12+ weeks
Quote SLA
< 24 hours, 24-48 hours, 3-5 business days, 1-2 weeks
Sample Return Policy
Return, Dispose, Both options
Minimum Project Size
<$10k, $10-25k, $25-50k, $50k+, No minimum
Pricing Model
Per project, Fixed package, Tiered, Custom
