HTW Lab
HTW Lab is a specialized biocompatibility testing laboratory providing ISO 10993 testing services for medical devices. The laboratory offers comprehensive biological safety evaluation including cytotoxicity, sensitization, irritation, and systemic toxicity testing to support FDA and EU MDR regulatory submissions.
HTW Lab is a dedicated biocompatibility testing laboratory specializing in ISO 10993 biological safety evaluation for medical devices. The laboratory provides comprehensive testing services including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), systemic toxicity (ISO 10993-11), genotoxicity (ISO 10993-3), and hemocompatibility (ISO 10993-4) testing. HTW Lab supports medical device manufacturers with testing programs designed to meet FDA 510(k), PMA, EU MDR, and other global regulatory requirements. The laboratory maintains GLP compliance and works with clients to develop efficient testing strategies that minimize costs while ensuring regulatory compliance.
About
**Who they are**
HTW Lab is a specialized biocompatibility testing laboratory with 42 years of experience, focusing on ISO 10993 testing services for medical devices. They aim to support regulatory submissions for bodies like the FDA and EU MDR.
**Expertise & scope**
* Cytotoxicity testing (ISO 10993-5)
* Skin, intradermal, and oral mucosal irritation testing (ISO 10993-10)
* Sensitization testing (ISO 10993-10)
* Bioburden testing (ISO 11737 series)
* Evaluation of systemic toxicity and pyrogenicity (ISO 10993-11 and ASTM)
* Testing within a risk management process (ISO 10993-1)
* Material characteristic analysis (ISO 10993-18)
**Reputation / proof points**
* 42 years of experience
HTW Lab is a specialized biocompatibility testing laboratory with 42 years of experience, focusing on ISO 10993 testing services for medical devices. They aim to support regulatory submissions for bodies like the FDA and EU MDR.
**Expertise & scope**
* Cytotoxicity testing (ISO 10993-5)
* Skin, intradermal, and oral mucosal irritation testing (ISO 10993-10)
* Sensitization testing (ISO 10993-10)
* Bioburden testing (ISO 11737 series)
* Evaluation of systemic toxicity and pyrogenicity (ISO 10993-11 and ASTM)
* Testing within a risk management process (ISO 10993-1)
* Material characteristic analysis (ISO 10993-18)
**Reputation / proof points**
* 42 years of experience
Additional information
HTW Lab provides comprehensive biological safety evaluations crucial for medical device regulatory submissions. Their services cover a range of ISO 10993 standards, including cytotoxicity, irritation, sensitization, and systemic toxicity. They also offer material characterization and testing within a risk management framework. Buyers should note that the laboratory observes closures for Christmas and New Year holidays.
Key Highlights
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Offers 42 years of experience in inspection services.
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“42 Years Of Experience”
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Specializes in Biocompatibility Testing for FDA and ISO 10993 standards.
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“Biocompatibility Testing For FDA-ISO 10993-HTW lab”
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Provides cytotoxicity testing according to ISO 10993-5.
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“Cytotoxicity test- ISO 10993-5”
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Conducts irritation and sensitization tests per ISO 10993-10.
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“Skin, intradermal and oral mucosal irritation test- ISO 10993-10 Sensitisation test- ISO 10993-10”
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Performs systemic toxicity and pyrogenicity testing under ISO 10993-11.
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“Systemic effects of systemic toxicity and pyrogenicity - ISO 10993-11 and ASTM:”
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Offers material characteristic analysis as per ISO 10993-18.
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“Material characteristic analysis-ISO10993-18”
Certifications & Trust Signals
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Operates as a third-party inspection service provider.
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“Internationally Certified Third-Party Inspection Services”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance testing
- Companies preparing FDA or EU MDR regulatory submissions
How engagement typically works
- Project-based testing services
- Consultative support for risk management integration
Typical deliverables
- Biocompatibility test reports
- Material safety evaluations
- Data for regulatory dossiers
Good to know
- Best when requiring specific ISO 10993 standard testing
- Consider holiday closures when planning project timelines
HQ:
US
Languages:
English
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18
Test Types Offered:
Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Pyrogenicity
Glp Compliant:
No
Has In House Toxicology:
No
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Is Accredited:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
< 24 hours
Rush Available:
Yes
Regions Served:
United States
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-18, ISO 11737 series
Test Types Offered
Cytotoxicity, Skin irritation, Intradermal irritation, Oral mucosal irritation, Sensitization, Bioburden, Systemic toxicity, Pyrogenicity, Material characteristic analysis
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Pricing Model
Per project
