7.9 Clinical evidence: The dossier should contain the clinical evidence that demonstr ...

1.4 If a manufacturer engages in only some operations subject to the requirements of ...

Purchasing information: Purchasing information shall describe the product to be purch ...

General (i) Case Report Forms are established to implement the clinical investigatio ...

Quality manual: The manufacturer shall establish and maintain a quality manual that i ...

4. Quality management system 4.1 General The manufacturer shall establish, document, ...

18.0 Shipping stability: This section should provide information on shipping stabilit ...

"specimen receptacle" means a device, whether vacuum type or not, specifically inten ...