Intertek
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, providing a wide range of services to various industries. They specialize in ensuring products meet stringent regulatory and safety standards.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* Expertise to support a broad spectrum of industries.
* Focus on ensuring products meet regulatory and safety requirements.
**Reputation / proof points**
* Global presence with extensive testing capabilities.
Intertek is a global leader in Total Quality Assurance, providing a wide range of services to various industries. They specialize in ensuring products meet stringent regulatory and safety standards.
**Expertise & scope**
* Biocompatibility testing services aligned with ISO 10993 standards.
* Expertise to support a broad spectrum of industries.
* Focus on ensuring products meet regulatory and safety requirements.
**Reputation / proof points**
* Global presence with extensive testing capabilities.
Additional information
Intertek's biocompatibility testing services are crucial for medical device manufacturers seeking to demonstrate product safety and compliance. Their comprehensive approach helps identify potential risks associated with materials and devices that come into contact with the human body. By engaging Intertek, clients can gain confidence in their product's safety profile, facilitating smoother regulatory submissions and market access.
Key Highlights
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
- Companies requiring regulatory compliance testing
How engagement typically works
- Project-based testing
- Consultative support
Typical deliverables
- Biocompatibility test reports
- Regulatory compliance assessments
Good to know
- Best when specific ISO 10993 testing is 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
