Medical Devices Certification_List of Mandatory documents

Client Name
:
SGS Certificate #:
Title
QA Manual
QA Procedures:
Control of documents (4.2.3)
Control of records (4.2.4)
Design Control (7.3)
Purchase (7.4)
Identification & Traceability (7.5.3)
Installation (7.5.1.2.2)
Servicing (7.5.1.2.3)
Sterilisation validation/ routine control
(7.5.2)
Preservation of products (7.5.5)
Control of measuring devices (7.6)
Customer feedback (8.2.1)
Internal Audits (8.2.2)
Control of NC products (8.3)
Analysis of data (8.4)
Advisory notices (8.5.1)
Corrective action (8.5.2)
Preventive action (8.5.3)
Risk management(7.1)
Notification of changes to SGS
Post Market surveillance/ Vigilance
procedure

Document No

Device master files (Technical files)

Sr.
No.
1
2
3
4

Product Group

Form: meddev/ I/01_Issue1

Version / Date

As below
Technical File No.

Model #