Filab Laboratory
FILAB
★★★★★
4.3
/ 5
•
25 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 are recognized for their expertise in ISO 10993-13 analysis, contributing to regulatory compliance and patient safety.
**Expertise & scope**
* Expertise in ISO 10993-13 standard for the identification and quantification of degradation products from polymer-based medical devices.
* Assessment of polymeric material degradation and their functional ability without adverse effects.
* Analysis to ensure patient safety by identifying and quantifying substances released from medical devices during use.
* Services extend to chemical analysis, materials characterization, and biocompatibility testing across various sectors including medical devices, pharmaceuticals, cosmetics, and aerospace.
**Reputation / proof points**
* Accredited by COFRAC ISO 17025.
* Holds Qualification Laboratoire from SAFRAN.
* Approved Vendor List (AVL) supplier for FRAMATOME.
* Approved by EDF for PMUC homologation analyses.
* Approved by DASSAULT AVIATION, positioning them as a reliable partner for the aerospace industry.
* Accredited for Crédit Impôt Recherche (CIR) until 2026 by the Ministry of Higher Education and Research.
Filab Laboratory is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices. They are recognized for their expertise in ISO 10993-13 analysis, contributing to regulatory compliance and patient safety.
**Expertise & scope**
* Expertise in ISO 10993-13 standard for the identification and quantification of degradation products from polymer-based medical devices.
* Assessment of polymeric material degradation and their functional ability without adverse effects.
* Analysis to ensure patient safety by identifying and quantifying substances released from medical devices during use.
* Services extend to chemical analysis, materials characterization, and biocompatibility testing across various sectors including medical devices, pharmaceuticals, cosmetics, and aerospace.
**Reputation / proof points**
* Accredited by COFRAC ISO 17025.
* Holds Qualification Laboratoire from SAFRAN.
* Approved Vendor List (AVL) supplier for FRAMATOME.
* Approved by EDF for PMUC homologation analyses.
* Approved by DASSAULT AVIATION, positioning them as a reliable partner for the aerospace industry.
* Accredited for Crédit Impôt Recherche (CIR) until 2026 by the Ministry of Higher Education and Research.
Additional information
Filab Laboratory's commitment to quality is underscored by its numerous accreditations and approvals, including COFRAC ISO 17025, SAFRAN, FRAMATOME, EDF, and DASSAULT AVIATION. These credentials demonstrate their capability to perform rigorous testing and analysis for demanding industries. Their specific focus on ISO 10993-13 testing for medical devices highlights their role in ensuring product safety and regulatory adherence. Buyers can expect a laboratory with a proven track record in chemical analysis and materials characterization, supporting product development and market access.
Key Highlights
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Specializes in ISO 10993-13 testing for polymer-based medical devices.
Source
“ISO 10993-13 medical device testing laboratory”
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Accredited by COFRAC ISO 17025.
Source
“Accréditations COFRAC ISO 17025”
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Holds supplier approvals from SAFRAN, FRAMATOME, EDF, and DASSAULT AVIATION.
Source
“FILAB a obtenu il y a plusieurs années la Qualification Laboratoire par le groupe SAFRAN... agrément fournisseur de FRAMATOME... agréé par EDF... agrément DASSAULT AVIATION.”
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Accredited for Crédit Impôt Recherche (CIR) until 2026.
Source
“L’agrément de FILAB au titre du Crédit Impôt Recherche a été reconduit par le Ministère de l’Enseignement Supérieur et de la Recherche jusqu’en 2026.”
Certifications & Trust Signals
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Independent laboratory with expertise in chemical analysis, materials characterization, and biocompatibility testing.
Source
“FILAB is an independent laboratory specializing in chemical analysis, materials characterization, and biocompatibility testing for medical devices.”
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Supports regulatory compliance and patient safety through specialized testing.
Source
“Ensuring patient safety by identifying and quantifying substances that may be released from a DM during use”
Buyer Snapshot
Best for
- Medical device manufacturers seeking ISO 10993-13 compliance testing.
- Companies requiring chemical analysis and materials characterization for product development.
- Aerospace and defense industries needing specialized material testing.
How engagement typically works
- Project-based analysis and testing.
- Collaborative approach to regulatory compliance.
- Expert consultation on material characterization.
Typical deliverables
- Biocompatibility test reports (ISO 10993-13).
- Chemical analysis reports.
- Materials characterization data.
- Degradation product identification and quantification.
Good to know
- Best when specific polymer-based medical device testing is required.
HQ:
France
Languages:
English
Timezones:
UTC+1
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 10993-12, ISO 10993-18
Test Types Offered:
Other
Is Accredited:
Yes
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)
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
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993-13
Test Types Offered
Chemical analysis, Materials characterization, Biocompatibility testing, Identification and quantification of degradation products
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Pricing Model
Per project
