Specifications

Approval Table
Document Doc.Id. Version
Name of document GR 21-005 01
1 PROJECT MANAGER YES NO NA
1.1
Coherence to specifications & technical documentation
✓
1.2
Procedures are safe, effective, accurate & complete
✓
1.3
Illustrations are technically accurate
✓
1.4
Warnings & cautions included where necessary
✓
1.5
Project Manager Signature
Approved
2 MARKETING & SALES YES NO NA
2.1
Document & language is accurate (Proofread)
✓
2.2
Material is professional
✓
2.3
Agrees with experience of intended user
✓
2.4
Marketing and Sales Manager Signature
Approved
3 QUALITY YES NO NA
3.1
Correct symbols are used
✓
3.2
Hazardous situations are highlighted with adequate symbols & warnings
✓
3.3
MDD and ISO 13485 requirements are met
✓
3.4
Requested changes (CR) are implemented
✓
3.5
Document ID is correct
✓
3.6
Document is within Intended Use
✓
3.7
All claims are correct according to regulatory approvals
✓
3.8
Quality Manager Signature
Approved
4 SUPPLY YES NO NA
4.1
Item numbers, terminology and pricing will be applicable
✓
4.2
The product (IFU) will work in production
✓
4.3
Supply Manager Signature
Approved
Template Doc.Id. Version
Core Text Template FL 09-04-01 TMP 03