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 testing and certification solutions provider with 42 years of experience, specializing in medical device testing and biocompatibility testing for FDA and ISO 10993 standards.
**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)
* Systemic toxicity and pyrogenicity testing (ISO 10993-11 and ASTM)
* Evaluation and 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 testing and certification solutions provider with 42 years of experience, specializing in medical device testing and biocompatibility testing for FDA and ISO 10993 standards.
**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)
* Systemic toxicity and pyrogenicity testing (ISO 10993-11 and ASTM)
* Evaluation and 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 biocompatibility testing services crucial for medical device manufacturers seeking FDA and ISO 10993 compliance. Their expertise covers a wide range of tests, including cytotoxicity, irritation, sensitization, and material characterization. For manufacturers navigating the complexities of regulatory submissions, HTW Lab offers testing within a risk management framework, aligning with ISO 10993-1. Engaging with HTW Lab for these services typically involves direct contact to discuss specific project needs and obtain detailed information on their testing methodologies and deliverables.
Key Highlights
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Offers 42 years of experience in internationally certified third-party inspection services.
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“Internationally Certified Third-Party Inspection Services - 42 Years Of Experience - HTM Lab”
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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 test- ISO 10993-5.
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“Cytotoxicity test- ISO 10993-5”
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Conducts Skin, intradermal and oral mucosal irritation tests per ISO 10993-10.
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“Skin, intradermal and oral mucosal irritation test- ISO 10993-10”
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Performs Sensitisation test- ISO 10993-10.
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“Sensitisation test- ISO 10993-10”
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Offers Bioburden test- ISO 11737 series.
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“Bioburden test- ISO 11737 series”
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Provides Systemic effects of systemic toxicity and pyrogenicity testing per ISO 10993-11 and ASTM.
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“Systemic effects of systemic toxicity and pyrogenicity - ISO 10993-11 and ASTM:”
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Conducts Evaluation and testing within a risk management process per ISO 10993-1.
Source
“Evaluation and testing within a risk management process-ISO10993-1”
Certifications & Trust Signals
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Internationally Certified Third-Party Inspection Services.
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“Internationally Certified Third-Party Inspection Services”
Buyer Snapshot
Best for
- Medical device manufacturers requiring ISO 10993 and FDA compliance testing.
- Companies needing detailed material characterization and risk management-based testing.
How engagement typically works
- Direct contact for project consultation.
- Service-based engagement for specific testing needs.
Typical deliverables
- Biocompatibility test reports.
- Material characteristic analysis reports.
- Testing within a risk management process.
Good to know
- Best when specific ISO 10993 and FDA testing is required.
HQ:
US
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
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, Hemocompatibility
Glp Compliant:
Yes
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:
3-5 business days
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
Test Types Offered
Cytotoxicity, Skin irritation, Intradermal irritation, Oral mucosal irritation, Sensitisation, 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
