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 :

  • Custom chemical analysis
    • Cleaning residue analysis following the ISO 19227 set : analysis of organic, inorganic and particulate contaminants
    • Analysis of undesirable substances (CMR substances, etc.)
    • Analysis of sterilization residue (ISO 10993-7) : Ethylene oxide, ethylene hydrochloride, ethylene glycol…

Development of new analytical techniques

  • Validation of new analytical techniques based on ICH Q2 standards
  • 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
    • Ceramic analysis and hydroxyapatite powder analysis in accordance with ISO 13779 : 2018
    • Polymer characterization (silicone, resin, elastomers…)
    • 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
    • Problems tied to chemical treatment (galvanization, passivation, anodization…)
    • Ruptures and fissures

Corrosion

  • Surface treatment peeling off
  • Industrial process audit

 

WHY FILAB ?

An experienced and approachable team

A COFRAC ISO 17025 accredited laboratory

A complete analytical fleet spread over 2100m²

Competitive timeframes and pricing

 

How to contact us ?

For more information, contact us via email at contact@filab.fr  or over the phone by calling +33 (0)3 80 52 32 05

 

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