QUALITY

ISO 13485

In development.

GOOD MANUFACTURE PRACTICES

EDQM

Our manufacturing process complies with the following regulations:

Europe: Directive 93/42 / CEE: Medical Devices Directive (MDD) and ISO 13485.

FDA: 21CFR part 820 - Quality System Regulation / Good Manufacturing Practice (GMP)

Our quality management system is fully based on ISO 13485 norms. Manuals and procedures can be shared with customers, if requested.