Laboratory analysis of Medical Devices
Medical device manufacturers must ensure the safety, performance, and regulatory compliance of their devices.
This notably involves characterizing device materials, identifying potential contaminants, and controlling residues resulting from manufacturing processes.
Thanks to its expertise in medical devices, the FILAB laboratory supports manufacturers in material analysis, substance identification, and failure investigations to help secure the market launch of their 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
Medical devices handled by the FILAB laboratory
Medical device analysis can be performed on a wide range of materials used in the healthcare sector:
- Medical implant manufacturers: metal alloys, titanium, surface coatings
- Polymer device manufacturers: medical-grade polymers, engineering plastics, composites
- Single-use device manufacturers: syringes, catheters, sterile devices
- Medical equipment manufacturers: electronic components, functional coatings, technical materials
- Medical subcontractors: raw materials, intermediate products, machined parts
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.
Our FAQ
To obtain a quote, you can contact our team via our contact form, by phone, or by email.
Simply tell us your requirements (type of material, desired analysis, applicable standards, urgency, quantity of samples, etc.). We will then send you a personalized technical and pricing proposal within 24-48 hours.
Turnaround times vary depending on the nature of the analysis and the complexity of the expert assessment project.
However, FILAB is committed to providing fast turnaround times tailored to your industrial constraints and urgent needs.
Using a specialized laboratory helps ensure the safety, compliance, and performance of a medical device. Thanks to advanced analytical techniques, these analysis can identify potential contamination, evaluate materials, and confirm compliance with international standards applicable to the medical sector.
Medical device expertise includes all analyses and evaluations used to characterize materials, identify substances present, analyze surfaces, and study residues from manufacturing processes in order to ensure the safety and compliance of devices.
Before placing a product on the market, medical device expertise helps demonstrate its safety and compliance with regulatory requirements. It also helps identify potential risks related to materials, contaminants, or manufacturing processes.
Analysis can be performed on various types of materials used in medical devices: polymers, ceramics, metal alloys, surface coatings, or composites.
Analyzing manufacturing residues helps verify the cleanliness of devices and ensure that industrial processes (cleaning, surface treatment, sterilization) do not leave behind undesirable substances that could affect product safety.
Analysis can be conducted in accordance with various international standards applicable to medical devices, including certain standards from the ISO 10993 series for chemical characterization or biocompatibility, as well as standards related to cleanliness or process validation.
Medical device analysis may be required in several situations: development of a new product, failure investigation, production quality control, contamination studies, or preparation of a regulatory dossier.
To obtain a quote, you can contact our teams via our contact form, by phone, or by email, providing details about your needs (type of material, requested analysis, applicable standards, urgency, number of samples, etc.).
The turnaround time for receiving a quote for medical device expertise is generally 24 to 48 hours after your request has been received.
