FDA-registered laboratory (Medical Devices sector)
As a manufacturer, you want to export your medical devices to the USA
What is the FDA ?
The FDA (Food and Drug Administration) is the U.S. federal agency responsible for protecting and promoting public health. Its primary mission is to regulate and oversee the safety and efficacy of food products, drugs, medical devices, cosmetics, biological products and more. The FDA ensures that consumer products are safe, effective and properly labeled.
Control the conformity of your medical devices
As regulatory requirements in the medical device sector continue to evolve, the materials used must meet increasingly precise specifications in terms of product lifespan, environmental compatibility and non-toxicity for the human body. These standards apply to all types of medical devices, whether they are made of polymeric, ceramic or metallic materials. These strict regulations require you to carry out numerous quality controls on your medical devices.
To rise these technical challenges, you’re looking for a reliable, responsive
To meet these technical challenges and export your products to the USA, you are looking for a reliable and responsive chemical analysis laboratory with expertise in medical device analysis, capable of supporting you in the analysIs required by the FDA.
The FILAB laboratory is registered with the FDA and can help you analyse your medical devices for export to the USA.
Why choose FILAB for your analysis of Medical Devices exported to the USA ?
The FILAB laboratory is registered with the FDA and supports manufacturers exporting their medical devices to the USA, who are required to have their products analyzed by an FDA-registered laboratory.
FILAB provides medical device manufacturers with top-level human skills and state-of-the-art analytical equipment to offer them services that meet their compliance criteria, in compliance with regulatory standards for all types of medical device.
In addition, FILAB laboratory is ISO 17025 accredited by COFRAC to ISO 10993-18: for both organic and inorganic residue analysis. This complements our COFRAC ISO 17025 MD accreditations for HCT / COT analysis and inorganic residue analysis by ICP to ISO 19227 (more information at www.cofrac.fr – accreditation n°1-1793).
Our services dedicated to medical device analysis
The FILAB laboratory has developed a wide range of skills in chemical analysis and materials characterization to provide you with a comprehensive service for the chemical characterization of all your biomaterials:
- Chemical characterization of materials in accordance with ISO 10993-18:2018
- Calculation of ATE
- Validation of extraction completeness in accordance with ISO 10993-12
- Search for and determination of organic and inorganic residues by ICP, GC/MS, LC, HS/GCMS, CLI…
- Identification of impurities by LC-QTOF
- Analysis of cleaning residues in accordance with ISO 19227:2018
- HCT/COT analysis
- Analysis of inorganic residues
- Analysis of particulate contamination
- Development, transfer and validation of analytical methods
- Problem solving: part breakage, surface contamination, adhesion problems, corrosion, etc.
The positive aspects of FILAB
A highly qualified team
Responsiveness in responding to and processing requests
A complete analytical park of 2100m²
Tailor-made support
