Eurofins Medical Device Testing
★★★★★
3.0
/ 5
•
10,136 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 across the product lifecycle.
**Expertise & scope**
* Comprehensive testing and certification for medical devices.
* Services encompass chemical, physical, mechanical, clinical, environmental, and electrical safety testing.
* Support for regulatory programs and technical compliance files to facilitate global market access.
* Product inspections, including pre-shipment inspections.
**Reputation / proof points**
* Global presence with laboratories worldwide.
* Expertise in ensuring compliance with global regulatory standards.
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 across the product lifecycle.
**Expertise & scope**
* Comprehensive testing and certification for medical devices.
* Services encompass chemical, physical, mechanical, clinical, environmental, and electrical safety testing.
* Support for regulatory programs and technical compliance files to facilitate global market access.
* Product inspections, including pre-shipment inspections.
**Reputation / proof points**
* Global presence with laboratories worldwide.
* Expertise in ensuring compliance with global regulatory standards.
Additional information
Eurofins Medical Device Testing provides services that span the entire supply chain, from initial development to market release. Their scope includes ensuring social and environmental sustainability alongside technical compliance. Buyers can expect support in navigating complex regulatory landscapes to gain access to various global markets. The company's extensive network of laboratories offers a wide reach for testing and certification needs.
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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Services include chemical, physical, mechanical, clinical, environmental, and electrical safety testing.
Source
“Chemical, Physical, Mechanical, Clinical, Environmental, Electrical Safety, Performance, etc.”
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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
Buyer Snapshot
Best for
- Medical device manufacturers seeking comprehensive testing and certification.
- Companies requiring support with global regulatory compliance.
- Businesses needing product inspections and quality assurance.
How engagement typically works
- Project-based testing and certification.
- Consultative support for regulatory submissions.
- Global service delivery through a network of labs.
Typical deliverables
- Test reports and certificates.
- Technical compliance files.
- Inspection reports.
- Regulatory compliance guidance.
Good to know
- Best when requiring adherence to global regulatory standards.
- Suitable for devices needing a wide range of chemical, physical, and safety testing.
HQ:
US
Languages:
English
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 USP <87> and <88>.
Regions Served:
Czech Republic, Netherlands, New Zealand, Philippines, Switzerland, United Kingdom, UNITED ARAB EMIRATES, United States
Is Accredited:
Yes
Accreditation Body:
ANAB
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
