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.
* Specializes in ISO 10993-13 analysis.
* Supports regulatory compliance and patient safety for medical devices.
* Offers Moldflow simulation for industrial applications, focusing on plastic part success through design, material selection, and transformation parameters.
* Provides rheology expertise and uses Moldflow software to secure developments and resolve production issues.
* Capabilities include visualizing internal mold processes to avoid costly tooling modifications and production waste.
* Specific simulation applications 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.
* Accredited by EDF for PMUC analyses, including specific product families (ion exchange resins and conditioning products).
* Accredited by DASSAULT AVIATION, positioning FILAB as a reliable partner for the aeronautics sector.
* Accredited by Aubert & Duval for the analysis of solid materials and powders, particularly for ICP-AES analysis.
* Accredited for Research Tax Credit (CIR).
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.
* Specializes in ISO 10993-13 analysis.
* Supports regulatory compliance and patient safety for medical devices.
* Offers Moldflow simulation for industrial applications, focusing on plastic part success through design, material selection, and transformation parameters.
* Provides rheology expertise and uses Moldflow software to secure developments and resolve production issues.
* Capabilities include visualizing internal mold processes to avoid costly tooling modifications and production waste.
* Specific simulation applications 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.
* Accredited by EDF for PMUC analyses, including specific product families (ion exchange resins and conditioning products).
* Accredited by DASSAULT AVIATION, positioning FILAB as a reliable partner for the aeronautics sector.
* Accredited by Aubert & Duval for the analysis of solid materials and powders, particularly for ICP-AES analysis.
* Accredited for Research Tax Credit (CIR).
Additional information
Filab Laboratory serves a diverse range of sectors, including Health (Medical Devices, Pharmaceuticals, Cosmetics, Biopharmaceuticals), Aerospace, Defense, and various industrial applications such as Automotive, Energy/Nuclear, Luxury, Metallurgy, and Plastics/Polymers. Their accreditations, including COFRAC ISO 17025, and specific approvals from major industry players like SAFRAN, FRAMATOME, EDF, DASSAULT AVIATION, and Aubert & Duval, underscore their commitment to quality and reliability. For industrial applications, FILAB leverages Moldflow simulation to optimize plastic injection processes, providing data-driven insights to prevent production issues and reduce costs. This dual focus on analytical testing and simulation makes them a comprehensive partner for product development and validation.
Key Highlights
-
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.”
-
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.”
-
Holds COFRAC ISO 17025 accreditation.
Source
“Accréditations COFRAC ISO 17025”
-
Approved vendor for major industry players including SAFRAN, FRAMATOME, EDF, DASSAULT AVIATION, and Aubert & Duval.
Source
“FILAB has obtained Qualification Laboratoire by the SAFRAN group... obtained the supplier accreditation of FRAMATOME... agréé par EDF... agrément DASSAULT AVIATION... agréé par Aubert & Duval”
-
Offers Moldflow simulation to optimize plastic injection processes and resolve production issues.
Source
“FILAB combines its expertise in rheometry and the power of Moldflow software to secure your developments and solve your production problems.”
Certifications & Trust Signals
-
Accredited by COFRAC ISO 17025.
Source
“Accréditations COFRAC ISO 17025”
-
Qualified laboratory by SAFRAN.
Source
“FILAB has obtained Qualification Laboratoire by the group SAFRAN”
-
Approved supplier for FRAMATOME.
Source
“In 2020, the FILAB laboratory obtained the supplier accreditation of FRAMATOME”
-
Accredited by EDF for PMUC analyses.
Source
“The FILAB laboratory is accredited by EDF to carry out the analyses necessary for PMUC approval.”
-
Accredited by DASSAULT AVIATION.
Source
“In March 2025, the FILAB laboratory obtained the DASSAULT AVIATION accreditation.”
-
Accredited by Aubert & Duval for material analysis.
Source
“Since 2024, the FILAB laboratory has been accredited by Aubert & Duval for the analysis of solid materials and powders.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking biocompatibility testing.
- Companies requiring chemical analysis and materials characterization.
- Industrial clients needing simulation services for plastic injection molding.
How engagement typically works
- Project-based analysis and testing.
- Collaborative simulation and process optimization.
Typical deliverables
- Biocompatibility testing reports (ISO 10993).
- Chemical analysis and materials characterization data.
- Moldflow simulation reports and recommendations.
- Regulatory compliance support documentation.
Good to know
- Best when specific material or process challenges require expert analytical or simulation support.
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
