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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.
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