FILAB S.A.S

FILAB is an independent laboratory providing services in the fields of analytical chemistry and materials characterization. FILAB has extensive expertise in medical device testing, being the first French laboratory to be ISO 17025 accredited for the analysis of cleaning residues in accordance with the ISO 19227 standard, and for the chemical characterisation of medical device in accordance with the ISO 10993-18 standard.

The laboratory (100/+ people) also offers a full range of analytical services to support companies in the medical device sector, including:

• Biocompatibility testing : degradation studies (ISO 10993-13, ISO 10993-14 and ISO 10993-15) ; PMT characterisation (ISO 10993-19); nanomaterials testing (ISO 10993-22)…
• Polymers characterization
• R&D support : reverse-engineering, analytical development, ICH Q2 validation…
• Process validation : chemical treatment surface validation…
• Expertise and solving problem : failure analysis…
• Analysis of cleaning residues
• Training and Audit

The FILAB laboratory can provide you with support that goes beyond regulatory analyses, offering you personalised assistance to meet your specific needs… FILAB, a laboratory with expertise in analysis of medical device.