Intertek
★★★★★
2.8
/ 5
•
22 reviews
Intertek offers biocompatibility testing services, ensuring your products meet stringent regulatory and safety standards. Their expertise supports a wide range of industries.
Intertek is a global leader in providing comprehensive testing, inspection, and certification services. For the biocompatibility testing directory, they offer specialized expertise to ensure that medical devices and materials are safe for their intended use. This involves rigorous evaluation against international standards to mitigate risks and facilitate market access. Their services are crucial for manufacturers seeking to validate the safety and performance of their products. Intertek's commitment to quality and accuracy helps clients navigate complex regulatory landscapes and bring innovative solutions to market with confidence. They leverage extensive scientific knowledge and state-of-the-art facilities to deliver reliable results.
About
**Who they are**
Intertek is a global leader in Total Quality Assurance, offering a comprehensive suite of services including biocompatibility testing. They help ensure products meet stringent regulatory and safety standards across various industries.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* Expertise in ensuring products meet regulatory and safety requirements.
* Support for a wide range of industries requiring product safety validation.
**Reputation / proof points**
* Global presence with extensive testing capabilities.
Intertek is a global leader in Total Quality Assurance, offering a comprehensive suite of services including biocompatibility testing. They help ensure products meet stringent regulatory and safety standards across various industries.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* Expertise in ensuring products meet regulatory and safety requirements.
* Support for a wide range of industries requiring product safety validation.
**Reputation / proof points**
* Global presence with extensive testing capabilities.
Additional information
Intertek's biocompatibility testing services are crucial for medical device manufacturers and other product developers who need to demonstrate the safety of materials that come into contact with the human body. Their testing helps navigate complex global regulatory landscapes, ensuring market access and consumer confidence. Engage with Intertek to validate product safety and compliance.
Key Highlights
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Offers comprehensive biocompatibility testing services.
Source
“Intertek offers biocompatibility testing services, ensuring your products meet stringent regulatory and safety standards.”
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Supports a wide range of industries with product safety expertise.
Source
“Their expertise supports a wide range of industries.”
Certifications & Trust Signals
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Global leader in Total Quality Assurance.
Source
“Intertek is a global leader in Total Quality Assurance”
Buyer Snapshot
Best for
- Medical device manufacturers
- Product developers requiring safety validation
- Companies seeking regulatory compliance for materials
How engagement typically works
- Project-based testing
- Consultative approach to compliance
Typical deliverables
- Biocompatibility test reports
- Regulatory compliance documentation support
Good to know
- Best when specific ISO 10993 testing protocols are required.
HQ:
United States
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, United Kingdom, Switzerland, Canada, Japan, Brazil
Industries:
Medical Devices
Pricing model:
Custom pricing
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
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Both options
Regions Served:
United States, Europe, Asia, Canada, Mexico, Brazil, China, Hong Kong SAR, China, United Arab Emirates, Argentina, Bulgaria, Chile, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Guatemala, Italy, Netherlands, Norway, Peru, Portugal, Spain, Sweden, Switzerland, Thailand, Vietnam
Accreditation Body:
ANAB
Toxicology Capabilities:
In vitro and in vivo toxicology testing for medical devices.
Rush Available:
Yes
Sample Requirements:
Samples must be sterile and provided in appropriate containers. Specific quantities and dimensions will be discussed during project initiation.
Nda Support:
Yes
Minimum Project Size:
$25-50k
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Return, Dispose
Minimum Project Size
$50k+
Pricing Model
Per project
