ISO 13485

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Quality System for Medical Devices

Production and trading System for Medical Devices.

It concerns the companies that trade and distribute medical devices and describes principles and guidelines of good practice of storage & distribution of these products.

(Ministerial Decision ΔΥ8δ / ΓΠ οικ / 1346, ΦΕΚ32Β - 16.01.2004)