TÜV SÜD
★★★★★
3.3
/ 5
•
204 reviews
TÜV SÜD is a leading global testing, inspection, and certification organization. They offer comprehensive biocompatibility testing services for medical devices.
TÜV SÜD is a globally recognized leader in the field of testing, inspection, and certification. With a strong commitment to safety and quality, they provide a wide range of services to various industries. For the biocompatibility testing directory, TÜV SÜD offers specialized expertise in assessing the biological safety of medical devices. Their rigorous testing protocols ensure that devices meet stringent regulatory requirements, providing manufacturers with the confidence needed to bring safe and effective products to market. Their services encompass a thorough evaluation of materials and device components to identify potential biological risks. This includes a comprehensive understanding of relevant international standards and regulatory frameworks. TÜV SÜD's experienced team of scientists and engineers work closely with clients to design and execute customized testing strategies, ensuring compliance and facilitating market access for medical devices worldwide.
About
**Who they are**
TÜV SÜD is a globally recognized leader in testing, inspection, and certification services. They offer specialized expertise in ensuring the safety and compliance of medical devices.
**Expertise & scope**
- Comprehensive biocompatibility testing for medical devices, adhering to international standards.
- Services designed to meet regulatory requirements for market access.
**Reputation / proof points**
- A leading global testing, inspection, and certification organization.
TÜV SÜD is a globally recognized leader in testing, inspection, and certification services. They offer specialized expertise in ensuring the safety and compliance of medical devices.
**Expertise & scope**
- Comprehensive biocompatibility testing for medical devices, adhering to international standards.
- Services designed to meet regulatory requirements for market access.
**Reputation / proof points**
- A leading global testing, inspection, and certification organization.
Additional information
When engaging TÜV SÜD for biocompatibility testing, buyers can expect a structured approach focused on regulatory compliance. The process typically involves detailed analysis and testing to confirm that medical devices do not elicit adverse biological responses. Buyers should be prepared to provide comprehensive device information and material specifications to facilitate accurate testing protocols. Deliverables often include detailed test reports that support regulatory submissions.
Certifications & Trust Signals
-
Globally recognized testing, inspection, and certification organization.
Source
“TÜV SÜD is a globally recognized testing, inspection and certification organization.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing.
- Companies requiring ISO 10993 compliance verification.
How engagement typically works
- Project-based testing.
- Consultative support for compliance.
Typical deliverables
- Biocompatibility test reports.
- Compliance documentation.
Good to know
- Best when specific device materials and intended use are clearly defined.
HQ:
Germany
Languages:
English
Status:
listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
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
Accreditation Body:
DAkkS
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
In vitro and in vivo toxicology studies
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Sample Return Policy:
Both options
Nda Support:
Yes
Minimum Project Size:
$25-50k
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility testing
