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 COFRAC ISO 17025 accredited laboratory

  • (Litters available on www.cofrac.com - Accreditation number: 1-1793)

  • A complete analytical park of 2100m²

  • Tailor-made support

  • A SAFRAN approval