Technical File Checklist

NO.
1
2
3
4

5
6
7
8

9
10
11
12
13

14

15
16
17
18
19
20

21
22
23
24
25
26

27
28
29
30
31
32

33
34
35
 Technical File Checklist
SYRINGE
CONTENTS DESCRIPTION
Table of Content
General information concerning the structure and use
EC declaration of conformity and classification to 93/42/EEC annex IX
Name and address of the manufacturer / European Representative and any manufacturing plants
Product description
Product description including any variants
Photographs of the product
Photographs of product usage
Brochures, advertising, catalogues (if available)
Product specifications
List of applicable standards
Parts list, list of components
Assembly and/or manufacturing drawings
Sub-assembly drawings, drawings of components (circuitry)
Specifications of materials used inc. data sheets
In case of a drug-device combination: statement about the substance(s) used (if applicable results
consultation- procedure)
Manufacturing specification
Sterilization specification
Packaging specification
QA specification (e.g. QC specs, in-process and end-controls, end-release etc.)
Labelling, accompanying documents, package insert (e.g. EN 980, ISO 15223)
Description about the creation of a Lot or Charge No.
Instructions for use (e.g. EN 1041)
Intended / clinical use
Indications, contra-indications
Operating instructions, instructions for use
Warnings / precautions
Service Manual
OEM contracts or supplier certificates
Product verification
Testing data and reports, functionality studies, wet lab or bench top testing
Materials certificates/reports on stability, biological tests, cleanroom-surveillance
EMC testing and certificates
Compatibility studies (connection to other devices)
Risk management- documentation (EN ISO 14971)
Clinical data (e.g. Article 15 / annex 10, MEDDEV 2.7.1, EN 14155-1/-2)
Product validation
Validation of the packaging/ageing studies
Process validation (e.g. sterilization, manufacturing, production)
Software validation
CHECKLIST
Belum Fix
OK
Belum ada
OK

OK
OK
Belum ada

Proses
OK
OK
Proses
OK

Not yet

OK
OK
OK
OK

OK

Ada di
kemasan

OK

OK
OK

Belum ada
OK
Belum ada

OK
Belum ada