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Laboratory analysis of Medical Devices
Are you looking for a competent, specialized and ISO 17025 accredited laboratory for scopes specific to Medical Devices?
By combining analytical tools specific to medical devices with reliable and accurate scientific interpretations, FILAB assists manufacturers in marketing their medical devices.
As the first French laboratory to be ISO 17025 accredited by COFRAC for cleaning residue analysis in accordance with the ISO 19227 set of standards and material characterization in accordance with ISO 10993-18, FILAB has the expertise and the complete analytical fleet needed to assist companies in the medical device industry.
FILAB most notably provides the following services :
CHEMICAL ANALYSIS
Cleaning residue analysis following the ISO 19227 set : analysis of organic, inorganic and particulate contaminants
Analysis of sterilization residue (ISO 10993-7) : Ethylene oxide, ethylene hydrochloride, ethylene glycol…
Validation of new analytical techniques based on ICH Q2 standards
Analysis of undesirable substances (CMR substances, etc.)
Development of new analytical techniques
Chemical characterization of materials based on the ISO 10993-18 : 2020 standard
Exhaustive extraction (ISO 10993-12)
Extractables and Leachables : FTIR, HS-GC/MS, GC/MS, LC-QToF/MS, ICP/MS, IC
Material characterization
Nanomaterial characterization based on the ISO 10993-22 standard
Polymer characterization (silicone, resin, elastomers…)
Ceramic analysis and hydroxyapatite powder analysis in accordance with ISO 13779 : 2018
Chemical analysis of metallic alloys, determination of grades
Surface characterization
Ceramic analysis and hydroxyapatite powder analysis in accordance with ISO 13779-3
Expert analysis and problem solving
Identification surface contaminants
Ruptures and fissures
Surface treatment peeling off
Problems tied to chemical treatment (galvanization, passivation, anodization…)
Corrosion
Industrial process audit
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
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