Eurofins Medical Device Testing
★★★★★
2.8
/ 5
•
10,153 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 network of laboratories providing comprehensive testing and certification services for medical devices, ensuring product safety, efficacy, and compliance with international regulatory standards.
**Expertise & scope**
* Offers a broad spectrum of testing, including chemical, physical, mechanical, clinical, environmental, and electrical safety assessments.
* Provides services to facilitate product access to global markets through regulatory programs and technical compliance files.
* Conducts product inspections on-site, such as pre-shipment inspections.
* Covers a vast range of consumer products, ensuring compliance with global standards.
**Reputation / proof points**
* Global presence with laboratories across multiple countries, including the United States, United Kingdom, Switzerland, and the United Arab Emirates.
* Services encompass quality assurance and control throughout the supply chain.
Eurofins Medical Device Testing is a global network of laboratories providing comprehensive testing and certification services for medical devices, ensuring product safety, efficacy, and compliance with international regulatory standards.
**Expertise & scope**
* Offers a broad spectrum of testing, including chemical, physical, mechanical, clinical, environmental, and electrical safety assessments.
* Provides services to facilitate product access to global markets through regulatory programs and technical compliance files.
* Conducts product inspections on-site, such as pre-shipment inspections.
* Covers a vast range of consumer products, ensuring compliance with global standards.
**Reputation / proof points**
* Global presence with laboratories across multiple countries, including the United States, United Kingdom, Switzerland, and the United Arab Emirates.
* Services encompass quality assurance and control throughout the supply chain.
Additional information
Eurofins Medical Device Testing supports clients in navigating complex regulatory landscapes by offering services that ensure product safety and efficacy. Their scope includes various testing methodologies to meet global market access requirements. Buyers can expect a comprehensive approach to quality assurance and control, extending across the entire product supply chain. The organization emphasizes compliance with international standards, providing essential data for regulatory submissions and market entry.
Key Highlights
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Offers comprehensive testing and certification services for medical devices.
Source
“Eurofins Medical Device Testing offers comprehensive testing and certification services for medical devices.”
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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 services to help products access global markets.
Source
“Regulatory programs, Technical Compliance Files and more to help your products access global markets.”
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Conducts on-site product inspections, including pre-shipment inspections.
Source
“Product inspections on-site: IPI, DuPro, Pre-shipment inspections, Picking, Loading Check…”
Certifications & Trust Signals
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Global network of laboratories with presence in the United States, United Kingdom, Switzerland, and the United Arab Emirates.
Source
“Group Menu -> Czech Republic Netherlands New Zealand Philippines Switzerland United Kingdom UNITED ARAB EMIRATES United States”
Buyer Snapshot
Best for
- Medical device manufacturers seeking global regulatory compliance
- Companies requiring comprehensive product safety and efficacy testing
- Businesses needing support for market access in various international regions
How engagement typically works
- Project-based testing and certification
- Consultative support for regulatory programs
- On-site inspections and quality assurance
Typical deliverables
- Comprehensive test reports
- Certification documentation
- Technical compliance files
- Inspection reports
Good to know
- Best when requiring adherence to global regulatory standards for medical devices.
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
