Would you like to perform an analysis or 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 market launch of medical devices.
These standards aim to guarantee the quality and safety of these medical devices by analyzing and characterizing their properties and composition.
These standards apply to all types of medical devices, whether they are made of polymer, ceramic, or metallic materials.
Thanks to its extensive experience in the analysis and characterization of nanomaterials, FILAB laboratory is also able to perform nanomaterial analyses in accordance with medical standards.
Consequently, only a laboratory equipped with state-of-the-art analytical facilities capable of performing all kinds of analyses can analyze and characterize products in accordance with medical standards.
Why perform an analysis or characterization according to medical standards?
The analysis of medical devices according to medical standards (such as ISO 10993, the European MDR, and FDA requirements) is a crucial and mandatory step for several fundamental reasons. It is not merely a formality, but an approach that directly 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 effectiveness (biocompatibility)
Regulatory compliance and market access
- Operational and financial benefits for the company
FILAB offers analysis and characterization services according to medical standards
Why choose FILAB for analysis according to medical standards?
To support manufacturers in the development and quality control of their products while keeping pace with regulatory changes, the FILAB laboratory provides access to a state-of-the-art analytical platform, enabling analysis and characterizations according to various medical standards.
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
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Characterization of passivation on the surface of medical devices 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 to be used alone or in combination in humans for medical purposes. This includes the diagnosis, prevention, monitoring, treatment, or alleviation of a disease. Examples range from dressings and surgical gloves to implants, prostheses, MRI scanners, 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) in order to obtain marketing authorization.
Commercial credibility: compliance with standards strengthens healthcare professionals’ and consumers’ confidence in your product.
Biocompatibility is the ability of a material or device to interact with living tissues without causing adverse reactions (toxic, inflammatory, allergic, etc.). Biocompatibility testing, in accordance with ISO 10993, is mandatory for all devices that come into contact with the human body, even for a short period.
