You wish to carry out analysis and characterization according to medical standards
Medical standards in the manufacture of medical devices
First of all, there are a large number of medical standards governing the marketing of medical devices.
These standards aim to guarantee the quality as well as the non-dangerousness of these medical devices by analyzing and testing their properties as well as their composition.
These standards apply to all types of medical devices whether they are composed of polymeric, ceramic or even metallic materials.
Due to its extensive experience in the analysis and characterization of nanomaterials, the FILAB laboratory is also able to carry out analysis of nanomaterials according to medical standards.
Consequently, only a laboratory with a state-of-the-art analytical park capable of carrying out all kinds of analyzes is able to analyze and characterize products according to medical standards.
Why carry out an analysis or characterization according to medical standards?
Analyzing medical devices according to medical standards (such as ISO 10993, European MDR, FDA requirements) is a crucial and mandatory step for several fundamental reasons. It is not a mere formality, but a process that impacts patient safety, the company’s credibility, and its ability to operate in the global market.
Analysis according to medical standards
Patient safety and clinical efficacy (biocompatibility)
Regulatory compliance and market access
Operational and financial benefits for the company
FILAB offers you its analysis and characterization services according to medical standards
Why choose FILAB for an analysis according to medical standards?
In order to support manufacturers in the development and quality control of their products, by following regulatory changes, the FILAB laboratory provides a state-of-the-art analytical park of 5200m², enabling analysis and characterization according to the various medical standards.
FILAB is the only laboratory to be COFRRAC ISO 17025 accredited for all three material degradation tests:
- ISO 10993-13: polymers,
- ISO 10993-14: ceramics,
- ISO 10993-15: metals
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Characterization of passivation on the surface of DM according to ASTM A967/A967M and ASTM F86-21
Passivation according to ASTM F86-21
FAQ
A medical device is any instrument, apparatus, implant, reagent, or software intended for use alone or in combination in humans for medical purposes. This includes the diagnosis, prevention, monitoring, treatment, or mitigation of disease. Examples range from surgical dressings and gloves, implants, prosthetics, to MRIs and pacemakers.
Analyzing your device is essential for three main reasons:
- Patient safety: to ensure that the device is safe, effective, and does not pose unacceptable risks to users.
- Regulatory compliance: to meet the requirements of health authorities (such as the FDA in the United States or the European Union) to obtain marketing authorization.
- Commercial credibility: compliance with standards strengthens the confidence of healthcare professionals and consumers in your product.
La biocompatibilité est la capacité d'un matériau ou d'un dispositif à interagir avec des tissus vivants sans provoquer de réactions indésirables (toxiques, inflammatoires, allergiques, etc.). Les tests de biocompatibilité, selon la norme ISO 10993, sont obligatoires pour tous les dispositifs en contact avec le corps humain, même pour une courte durée.
