Method Development for Medical Devices

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 analyses 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

The positive aspects of FILAB

  • A highly qualified team

  • Responsiveness in responding to and processing requests

  • A complete analytical park of 2100m²

  • Tailor-made support

Thank you !

Click here to know more about our services