Filab Laboratory
FILAB
★★★★★
4.3
/ 5
•
26 reviews
FILAB is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices. They offer expertise in ISO 10993-13 analysis, supporting regulatory compliance and patient safety.
FILAB is an independent laboratory founded in 1979, offering a wide range of analytical services and expertise. They specialize in chemical analysis, materials characterization, and regulatory testing, with a particular focus on biocompatibility testing for medical devices according to ISO 10993-13. Their services are crucial for ensuring patient safety by identifying and quantifying substances that may be released from medical devices. FILAB supports manufacturers in obtaining marketing authorization and improving device design by selecting safer materials. They are accredited by COFRAC ISO 17025 and hold various industry-specific accreditations, including SAFRAN, FRAMATOME, EDF (PMUC), and DASSAULT AVIATION. FILAB serves diverse sectors including Health (Medical devices, Pharmaceutical, Cosmetic, Biopharmaceutical), Aerospace, Defense, Automotive, Energy/Nuclear, Luxury, Metallurgy, and Plastics/Polymers. They are committed to providing high-level expertise and advanced analytical capabilities to help clients tackle complex challenges and make informed decisions.
About
**Who they are**
Filab Laboratory is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices. They offer expertise in ISO 10993-13 analysis, supporting regulatory compliance and patient safety.
**Expertise & scope**
* Expertise in chemical analysis and materials characterization.
* Specialization in biocompatibility testing for medical devices.
* Proficiency in ISO 10993-13 analysis.
* Support for regulatory compliance and patient safety.
**Reputation / proof points**
* Independent laboratory.
* Focus on supporting regulatory compliance and patient safety.
Filab Laboratory is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices. They offer expertise in ISO 10993-13 analysis, supporting regulatory compliance and patient safety.
**Expertise & scope**
* Expertise in chemical analysis and materials characterization.
* Specialization in biocompatibility testing for medical devices.
* Proficiency in ISO 10993-13 analysis.
* Support for regulatory compliance and patient safety.
**Reputation / proof points**
* Independent laboratory.
* Focus on supporting regulatory compliance and patient safety.
Additional information
FILAB leverages expertise in rheology and the Moldflow software to de-risk plastic part development and resolve production issues. Their numerical simulation capabilities allow for visualization within the mold, preventing costly tooling modifications and production scrap. They can predict injection pressures, clamping forces, identify weld lines, and air traps. FILAB serves various sectors including Medical Devices, Pharmaceuticals, Cosmetics, Biopharmaceuticals, Aeronautics, Space, Defense, Chemical Analysis, Automotive, Energy/Nuclear, Luxury, Metallurgy, and Plastics/Polymers.
Key Highlights
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Specializes in chemical analysis, materials characterization, and biocompatibility testing for medical devices.
Source
“FILAB is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices.”
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Offers expertise in ISO 10993-13 analysis to support regulatory compliance and patient safety.
Source
“They offer expertise in ISO 10993-13 analysis, supporting regulatory compliance and patient safety.”
Certifications & Trust Signals
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Independent laboratory.
Source
“FILAB is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing.
- Companies needing chemical analysis and materials characterization.
How engagement typically works
- Project-based analysis.
- Expert consultation for regulatory compliance.
Typical deliverables
- Biocompatibility testing reports.
- Chemical analysis data.
- Materials characterization results.
Good to know
- Best when specific ISO 10993 standards are required for medical devices.
HQ:
France
Languages:
English
Timezones:
UTC+1
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, France
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
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Minimum Project Size:
No minimum
Regions Served:
France
Toxicology Capabilities:
In vitro toxicology, in vivo toxicology, biocompatibility testing, analytical chemistry, microbiology, material characterization, and medical device testing.
Rush Available:
Yes
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-13
Test Types Offered
Biocompatibility testing, Chemical analysis, Materials characterization
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Pricing Model
Per project
