Storage: Policy on the storage of medical device. 9. Documentation: Arrangements for ...

Infrastructure The organisation shall determine, provide and maintain the infrastruct ...

Medicinal substances: Where the medical device incorporates a medicinal substance, th ...

Identification: The manufacturer shall identify the product by suitable means throug ...

(ii) Evidence of the ongoing revalidation of the process should also be provided. Typ ...

Where product requirements are changed, the manufacturer shall ensure that relevant d ...

Purchasing information shall describe the product to be purchased, including where ap ...

7.5.2 The manufacturer shall validate any processes for production and service provis ...