7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices

General :
Version:	1.0

Project :
Author:	Wolfgang Kern
Created:	07.03.2014 11:11:45
Modified:	13.09.2017 10:38:51

Diagram Elements :

Create shipment documents

Article master data

Delivery note

File product identification before delivery

File modules build into device

Sterilization lot report

Create sterilization report

Document module complete

Document device complete

Production complete report

Define device / module / work environment traceability

Overview assembling and testing

7.5.3.2 Traceability : 7.5.3.2 Traceability

7.5.3.2.2 Records of the name and address of the shipping package consignee shall be maintained

7.5.3.2.2 Agents or distributors shall maintain records of the distribution of implantable medical devices

7.5.3.2.2 Records of all components, materials and work environment conditions