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.
Services dedicated to the analysis of medical devices:
FILAB most notably provides the following services :
Biocompatibility
ISO 10993-22 : Characterisation of nanomaterials
ISO 10993-14 : Identification and quantification of degradation products of ceramic-based medical devices
ISO 10993-13: Identification and quantification of degradation products from polymer-based medical devices
ISO 10993-19 : PMT characterisation (physico-chemical, morphological and topographical)
ISO 10993-7 : Determination of ethylene oxide and ethylene hydrochloride
ISO 10993-15: Study of degradation products in your medical devices
The FILAB laboratory can provide you with support that goes beyond regulatory analysis, offering you personalised assistance to meet your specific needs… FILAB, a laboratory with expertise in analysis of medical device.
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
Around this topic
- ASTM F1185 analysis laboratory
- ASTM F1088-23 standard analysis laboratory
- Analysis laboratory to astm F1609-23 standard
- Laboratory analysis of your surgical implants according to the ASTM F1926 standard
- FDA-registered laboratory (Medical Devices sector)
- Analysis and characterization according to medical standards
- Surface analysis dedicated to Medical Devices
- Laboratory for the study of failures in the medical sector
- Dental cement analysis laboratory
- Liquid Chromatography (LC) Analysis for the Medical Device Industry
- Graphene analysis in FFP2 or KN95 masks
- Laboratory analysis of hydroxyapatite (PAH)
- Characterization of the passivation of medical devices
- Particle counting laboratory according to the AAMI TIR42 standard
- Laboratory analysis and accelerated aging tests on sterile packaging in accordance with the ASTM F1980 standard
- Laboratory analysis of your surgical implants according to the ASTM F138 standard
- Laboratory for the analysis of CMR substances in medical devices
- MEDICAL DEVICES : problematic adhesion of PAH on femoral head
- Laboratory characterization of materials used in medical devices
- ICP analysis laboratory for medical devices
