Manufacturers of medical devices, you wish to develop specific analytical methods for your products
In the context of a product launch, a process optimization or a regulatory evolution, the development of customized methods allows manufacturers from all over the Medical Devices industry to perform specific analysis for a given matrix, allowing to evaluate its performance and characteristics.
In the medical device sector, the development of analytical methods can have several objectives:
- Ensure the safety of the devices with respect to the associated standards
- Confirm the purity of raw materials used in manufacturing
- Ensure that products are free of contaminants and processing residues
Analytical methods can be developed and validated according to different standards, with the support of a qualified laboratory.
FILAB supports you in the development of specific analytical methods
FILAB is the first French laboratory to be COFRAC ISO 17025 accredited for the analysis of cleaning residues in accordance with ISO 19227 and for the chemical characterization of materials in accordance with ISO 10993-18. FILAB has the expertise and a complete range of analytical equipment to support companies in the medical device sector in the development of tailor-made analytical methods
Examples of services
Development of dosage methods for the analysis of cleaning residues (according to ISO 19227)
Development of analysis methods for sterilization residues (ISO 10993-7): ethylene oxide, ethylene hydrochloride, ethylene glycol...
Implementation of a dedicated operating procedure
Development of methods for the determination of undesirable substances (heavy metals, nitrosamines, phthalates...)
Development of analytical methods for extractables and leachables in the context of ISO 10993-18
Analytical validation
