Laboratory analysis of medical devices
Medical device manufacturers must guarantee the safety, performance, and regulatory compliance of their devices.
FILAB supports them in material characterization, contaminant identification, and failure analysis to help secure the market launch of medical devices.
Are you looking for a competent, specialized laboratory accredited to ISO 17025 for scopes specific to Medical Devices?
By combining analytical tools specific to medical devices with reliable and accurate scientific interpretations, FILAB supports manufacturers in bringing their Medical Devices to market or optimizing them.
FILAB has the expertise, accreditations, and a complete analytical platform to support companies in the medical device sector.
Services dedicated to medical device analysis:
FILAB provides the following services in particular:
Biocompatibility
ISO 10993-18: Chemical characterization of materials
ISO 10993-22: Nanomaterial characterization
ISO 10993-14 : Identification and quantification of degradation products from ceramic-based medical devices
ISO 10993-13: Identification and quantification of degradation products from polymer-based medical devices
ISO 10993-19: PMT characterization (physicochemical, morphological and topographical)
ISO 10993-7: Ethylene oxide and ethylene chlorohydrin assay
ISO 10993-15: Study of degradation products in your medical devices
FILAB is the only laboratory accredited by COFRRAC ISO 17025 for the three material degradation tests:
- ISO 10993-13: polymers,
- ISO 10993-14: ceramics,
- ISO 10993-15: metals
Extractables & Leachables
Discover our E&L services according to ISO 10993-18, carried out under ISO 17025 accreditation by COFRAC
- AET calculation
- Search and quantification of organic residues by GC\/MS, LC, HS\/GCMS
- Identification of impurities by LC-QTOF (database of more than 1,000 substances
- Validation of extraction completeness according to ISO 10993-12
- Search and quantification of organic and inorganic residues by ICP and CLI...
👉Learn more about extractables & leachables analysis (extractable and leachable testing analysis services)
analysis according to ASTM standards
ASTM F136 (titanium-6aluminum-4vanadium)
ASTM F139 (sheets and strips in forged 18 chromium-14 nickel-2.5 molybdenum stainless steel)
ASTM F1295 (wrought titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb) annealed.)
ASTM F1537 (orthopedic and wrought cobalt-28chromium-6molybdenum alloys)
ASTM F136 (titanium ELI alloys (extra low interstitial)
ASTM F1854 (stereological testing)
ASTM F2459-18 (electrodeposited coatings)
ASTM F90 (forged cobalt-20 chromium-15 tungsten-10 alloy)
ASTM F138 bars and wires in forged 18 chromium-14 nickel-2.5 molybdenum stainless steel
ASTM F1088-23 (beta-tricalcium phosphate)
ASTM F1536 (orthopedic bandage)
ASTM F1609-23 (calcium phosphate coatings)
ASTM F1813 (titanium-12 molybdenum-6 zirconium-2 iron alloy grinding products)
ASTM F1980 (sterile packaging)
ASTM F2743 (vascular stents)
Medical device expertise in detail
The medical device expertise covers all analyses used to assess the composition, cleanliness, and integrity of medical devices and their constituent materials.
These analytical investigations may include:
- the chemical characterization of materials (polymers, metals, coatings)
- the identification of unknown substances or contaminants organic or inorganic
- the analysis of manufacturing or cleaning residues
- the surface and coating analysis
- the failure or corrosion investigation
- the characterization of particles and contaminants
- study of DM failure or corrosion
Regulatory framework applicable to medical devices
In Europe, manufacturers must comply with Regulation (EU) 2017/745 on medical devices (MDR). This regulation notably requires a thorough assessment of materials, chemical substances, and device-related risks.
analysis carried out as part of medical device expertise may also fall within the requirements of international standards, such as certain standards in the ISO 10993 series, used for chemical characterization and biocompatibility assessment of materials.
Medical devices handled by the FILAB laboratory
Medical device analyses can be performed on many matrices used in the medical sector:
- Medical implant manufacturers : metal alloys, titanium, surface coatings
- Polymer device manufacturers : medical polymers, engineering plastics, composites
- Single-use device manufacturers : syringes, catheters, sterile devices
- Medical equipment manufacturers : electronic components, functional coatings, technical materials
- Medical sector subcontractors : raw materials, intermediate products, machined parts
The FILAB laboratory supports you beyond regulatory analysis by offering personalized assistance tailored to your specific challenges… FILAB, an expert laboratory in medical device analysis
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Using a specialized laboratory helps verify the safety, compliance, and performance of a medical device. Thanks to advanced analytical techniques, testing can identify any contamination, assess materials, and confirm compliance with the international standards applicable to the medical sector.
Medical device expertise brings together all the analysis and assessments used to characterize materials, identify the substances present, analyze surfaces, and study residues from manufacturing processes in order to ensure the safety and compliance of devices.
Before market launch, medical device testing helps demonstrate the product’s safety and compliance with regulatory requirements. It helps identify potential risks related to materials, contaminants, or manufacturing processes.
analysis can be carried out on different 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 performed in accordance with various international standards applicable to medical devices, including certain standards in the ISO 10993 series for chemical characterization or biocompatibility, as well as standards related to cleanliness or process validation.
Medical device testing can be carried out in several situations: development of a new product, investigation of a failure, production quality control, contamination study, or preparation of a regulatory submission.
To obtain a quote, you can contact our teams via our contact form, by phone, or by email, sending us your requirements (type of material, desired analysis, any applicable standard, urgency, number of samples, etc.).
The turnaround time for a quote for medical device testing is generally 24 to 48 hours after receipt of your request.
