HTW Lab
Verified
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.
**Expertise & scope**
* Provides comprehensive biological safety evaluation to support regulatory submissions for FDA and EU MDR.
* Offers testing for cytotoxicity (ISO 10993-5).
* Conducts skin, intradermal, and oral mucosal irritation tests (ISO 10993-10).
* Performs sensitization tests (ISO 10993-10).
* Includes bioburden testing (ISO 11737 series).
* Evaluates systemic toxicity and pyrogenicity (ISO 10993-11 and ASTM).
* Assists with evaluation and testing within a risk management process (ISO 10993-1).
* Conducts material characteristic analysis (ISO 10993-18).
**Reputation / proof points**
* 42 years of experience in inspection services.
HTW Lab is a specialized biocompatibility testing laboratory with 42 years of experience, focusing on ISO 10993 testing services for medical devices.
**Expertise & scope**
* Provides comprehensive biological safety evaluation to support regulatory submissions for FDA and EU MDR.
* Offers testing for cytotoxicity (ISO 10993-5).
* Conducts skin, intradermal, and oral mucosal irritation tests (ISO 10993-10).
* Performs sensitization tests (ISO 10993-10).
* Includes bioburden testing (ISO 11737 series).
* Evaluates systemic toxicity and pyrogenicity (ISO 10993-11 and ASTM).
* Assists with evaluation and testing within a risk management process (ISO 10993-1).
* Conducts material characteristic analysis (ISO 10993-18).
**Reputation / proof points**
* 42 years of experience in inspection services.
Additional information
HTW Lab's biocompatibility testing services are designed to support medical device manufacturers in meeting stringent regulatory requirements for market entry. Their expertise covers a range of ISO 10993 standards, crucial for demonstrating the safety of medical devices. Manufacturers seeking to submit for FDA or EU MDR approval can leverage HTW Lab's testing capabilities to validate device safety. The laboratory emphasizes a comprehensive approach, encompassing various biological safety evaluations necessary for a complete regulatory dossier.
Key Highlights
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Offers 42 years of experience in inspection services.
Source
“42 Years Of Experience”
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Specializes in ISO 10993 biocompatibility testing for medical devices.
Source
“Biocompatibility Testing For FDA-ISO 10993-HTW lab”
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Provides testing for cytotoxicity, irritation, sensitization, and systemic toxicity.
Source
“Cytotoxicity test- ISO 10993-5 Skin, intradermal and oral mucosal irritation test- ISO 10993-10 Sensitisation test- ISO 10993-10 Systemic effects of systemic toxicity and pyrogenicity - ISO 10993-11 and ASTM:”
Certifications & Trust Signals
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Provides testing to support FDA and EU MDR regulatory submissions.
Source
“The laboratory offers comprehensive biological safety evaluation including cytotoxicity, sensitization, irritation, and systemic toxicity testing to support FDA and EU MDR regulatory submissions.”
Buyer Snapshot
Best for
- Medical device manufacturers preparing FDA or EU MDR submissions
- Companies needing ISO 10993 compliant testing
How engagement typically works
- Project-based testing services
- Consultative approach to safety evaluation
Typical deliverables
- Biocompatibility test reports
- Biological safety evaluation data
- Material characterization reports
Good to know
- Best when specific ISO 10993 testing is required for regulatory compliance.
HQ:
US
Website:
htwlab.com
Public email:
marketing@szhtw.com.cn
Phone:
252.227-7015
Languages:
English
Access:
Verified
Claim status:
Claimed
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
