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.