DOXPUB 09-0180-SOP-1.0 PDF

Name:
DOXPUB 09-0180-SOP-1.0 PDF

Published Date:
11/01/2004

Status:
Active

Description:

EC Notification of Change Procedure

Publisher:
Doxpub, Inc.

Document status:

Active

Format:

Electronic (PDF)

Delivery time:

10 minutes

Delivery time (for Russian version):

200 business days

SKU:

This document defines which changes to the Quality System and/or Product Design require approval from the Notified Body (Europe) pior to implementation, and it also explains the strategy toward voluntary notification of changes that do not require further approval of the notified body but that are neverhteless notified because of their importance. A change management flowchart is included. This document adheres to Medical Device directive 93/42/EEC.

Edition :	1
File Size :	1 file , 67 KB
Number of Pages :	3
Published :	11/01/2004

History

DOXPUB 09-0180-SOP

Published Date: 08/01/2007

EC Notification of Change Procedure

$5.7

DOXPUB 09-0180-SOP-1.0

Published Date: 11/01/2004

EC Notification of Change Procedure

$18

Related products

DOXPUB 09-0178-SOP

Published Date: 08/01/2007

Medical Device Reporting: Europe

$32.7

DOXPUB 09-0179-SOP

Published Date: 08/01/2007

Medical Device Reporting: USA

$17.7

DOXPUB 12-0004-SOP

Published Date: 08/01/2007

Quality System/Regulatory Requirements Training

$14.7

DOXPUB 09-0014-SOP

Published Date: 08/01/2007

Product Recall Procedure: USA

$14.7

Best-Selling Products

ISO/DIS 10360-5:1998

Published Date: 07/01/1998

Geometrical Product Specifications (GPS) - Acceptance and reverification tests for coordinate measuring machines (CMM) - Part 5: CMMs used with multiple styli

$9.9

ISO/DIS 11608-3:1998

Published Date: 12/01/1998

Pen-Injectors for Medical Use - Part 3: Finished Cartridges - Requirements and Test Methods

$15.3

ISO/DIS 11614:1994

Published Date: 05/26/1994

Reciprocating Internal Combustion Compression-Ignition Engines - Apparatus for Measurement of the Opacity and for Determination of the Light Absorption Coefficient of Exhaust Gas - DRAFT

$22.5

ISO/DIS 1179-2:1995

Published Date: 09/01/1995

Connections for General Use and Fluid Power - Ports and Stud Ends with ISO 228-1 Threads with Elastomeric or Metal-to-Metal Sealing - Part 2: Heavy-Duty (S series) and Light-Duty (L series) Stud Ends with Elastomeric Sealing (type E) (Revision of ISO 1179:1981)

$9.9

ISO/DIS 1179-3:1995

Published Date: 09/01/1995

Connections for General Use and Fluid Power - Ports and Stud Ends with ISO 228-1 Threads with Elastomeric or Metal-to-Metal Sealing - Part 3: Light-Duty (L series) Stud Ends with Sealing by O-Ring with Retaining Ring (Types G and H) (Revision of ISO 1179:1981)

$11.4

ISO/DIS 1179-4:1995

Published Date: 09/01/1995

Connections for General Use and Fluid Power - Ports and Stud Ends with ISO 228-1 Threads with Elastomeric or Metal-to-Metal Sealing - Part 4: Stud Ends for General Use Only with Metal-to-Metal Sealing (Type B) (Revision of ISO 1179:1981)

$9.9