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 offering ISO 10993 testing services for medical devices. With a focus on biological safety evaluation, they 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)
* 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 (mentioned on multiple pages, though specific founding year not stated)
HTW Lab is a specialized biocompatibility testing laboratory offering ISO 10993 testing services for medical devices. With a focus on biological safety evaluation, they 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)
* 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 (mentioned on multiple pages, though specific founding year not stated)
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. For specific testing needs beyond those listed, buyers are encouraged to contact HTW Lab directly for more information.
Key Highlights
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Specializes in ISO 10993 biocompatibility testing for medical devices.
Source
“HTW Lab is a specialized biocompatibility testing laboratory providing ISO 10993 testing services for medical devices.”
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Offers comprehensive biological safety evaluation services.
Source
“The laboratory offers comprehensive biological safety evaluation including cytotoxicity, sensitization, irritation, and systemic toxicity testing”
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Supports FDA and EU MDR regulatory submissions.
Source
“to support FDA and EU MDR regulatory submissions.”
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Extensive experience with 42 years in inspection services.
Source
“Internationally Certified Third-Party Inspection Services - 42 Years Of Experience - HTM Lab”
Certifications & Trust Signals
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42 years of experience in inspection services.
Source
“Internationally Certified Third-Party Inspection Services - 42 Years Of Experience - HTM Lab”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993 compliance testing
- Companies preparing FDA or EU MDR regulatory submissions
How engagement typically works
- Direct service engagement
- Consultation for specific testing needs
Typical deliverables
- Biocompatibility test reports
- Biological safety evaluation data
Good to know
- Best when specific ISO 10993 testing is required for medical devices.
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
