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, materials characterization, and biocompatibility testing for medical devices.
* Specializes in ISO 10993-13 analysis.
* Offers simulation Moldflow for industrial applications, including plastic part success, injection process optimization, and polymer transformation mastery.
* Provides rheology analysis and digital simulation to visualize internal mold processes, reducing costly tooling modifications and production waste.
* Capabilities include balancing feed channels, predicting injection pressures and clamping forces, and identifying weld lines and air traps.
**Reputation / proof points**
* Accredited by COFRAC ISO 17025.
* Holds Qualification Laboratoire from SAFRAN for procedures GRP-0087 and GRM-0123.
* Approved Vendor List (AVL) supplier for FRAMATOME.
* Approved by EDF for PMUC analyses, including specific product families.
* Accredited by DASSAULT AVIATION, positioning them as a reliable partner for the aeronautics industry.
* Accredited by Aubert & Duval for the analysis of solid materials and powders, serving the aeronautics, medical device, and defense sectors.
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, materials characterization, and biocompatibility testing for medical devices.
* Specializes in ISO 10993-13 analysis.
* Offers simulation Moldflow for industrial applications, including plastic part success, injection process optimization, and polymer transformation mastery.
* Provides rheology analysis and digital simulation to visualize internal mold processes, reducing costly tooling modifications and production waste.
* Capabilities include balancing feed channels, predicting injection pressures and clamping forces, and identifying weld lines and air traps.
**Reputation / proof points**
* Accredited by COFRAC ISO 17025.
* Holds Qualification Laboratoire from SAFRAN for procedures GRP-0087 and GRM-0123.
* Approved Vendor List (AVL) supplier for FRAMATOME.
* Approved by EDF for PMUC analyses, including specific product families.
* Accredited by DASSAULT AVIATION, positioning them as a reliable partner for the aeronautics industry.
* Accredited by Aubert & Duval for the analysis of solid materials and powders, serving the aeronautics, medical device, and defense sectors.
Additional information
Filab Laboratory supports a range of industrial sectors, including Health (Medical Device, Pharmaceutical, Cosmetic, Biopharmaceutical), Aerospace, Defense, Automotive, Energy/Nuclear, Luxury, Metallurgy, and Plastics/Polymers. Their services are designed to assist in regulatory compliance and product development within these diverse fields. The laboratory emphasizes providing real data for precise calculations in their simulation services, aiming to secure developments and resolve production issues for their clients.
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.
Source
“They offer expertise in ISO 10993-13 analysis, supporting regulatory compliance and patient safety.”
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Provides simulation Moldflow for industrial applications, including plastic part success and injection process optimization.
Source
“FILAB combines its expertise in rheometry and the power of Moldflow software to secure your developments and solve your production problems.”
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Accredited by COFRAC ISO 17025.
Source
“Accréditations COFRAC ISO 17025”
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Holds accreditations and qualifications from major industry players like SAFRAN, FRAMATOME, EDF, and DASSAULT AVIATION.
Source
“FILAB has obtained Laboratory Qualification from the SAFRAN group... FILAB laboratory has obtained supplier accreditation from FRAMATOME... FILAB laboratory is approved by EDF... FILAB laboratory has obtained accreditation from DASSAULT AVIATION.”
Certifications & Trust Signals
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Accredited by COFRAC ISO 17025.
Source
“Accréditations COFRAC ISO 17025”
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Qualified Laboratory by SAFRAN.
Source
“FILAB has obtained Qualification Laboratoire by the SAFRAN group...”
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Approved Vendor List (AVL) supplier for FRAMATOME.
Source
“In 2020, the FILAB laboratory obtained supplier accreditation from FRAMATOME and is now part of the AVL...”
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Accredited by DASSAULT AVIATION.
Source
“In March 2025, the FILAB laboratory obtained accreditation from DASSAULT AVIATION.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing.
- Companies requiring chemical analysis and materials characterization.
- Industrial clients needing simulation and rheology expertise.
How engagement typically works
- Project-based analysis and testing.
- Collaborative problem-solving for production issues.
Typical deliverables
- Biocompatibility test reports.
- Chemical analysis reports.
- Materials characterization data.
- Moldflow simulation results.
- Rheological analysis data.
Good to know
- Best when specific material or device analysis is required.
- Best when regulatory compliance testing is a priority.
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 10993-18
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Implantation, Hemocompatibility, 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:
Filab Laboratory offers a comprehensive suite of biocompatibility testing services, including cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation, hemocompatibility, and biodegradation studies. They are GLP compliant and have in-house toxicology capabilities.
Rush Available:
Yes
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-13
Test Types Offered
Chemical analysis, Materials characterization, Biocompatibility testing
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Pricing Model
Per project
