Regulatory basis, reference documents 

21 CFR Part 820 – Quality System Regulation, Subpart C – Design Controls, 820.30 Design controls

ISO 13485:2016: Medical Devices – Quality management systems ¬Requirements for regulatory purposes

FDA/CDRH – Design Control Guidance for Medical Device Manufacturers, March 11, 1997

Table of Content:

1     Purpose

2     Objective

3     Regulatory basis, reference documents

4     Responsibility and accountability

4.1       Design Review Committee

4.2       Quality Assurance

4.3       Project Leader (PL) / Head of Engineering (HE)

4.4       Function / Area Leaders

5     Related documents

6     Definitions

7     Procedure

7.1       General Maintenance of Design History File

7.2       Content of the DHF

7.3       Day to day DHF work

7.4       Numbering of the Design History File

7.5       Security of Design History File Information

8     Attachments

9     SOP distribution

10         Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 8 pages procedure

The post Design History File (DHF) SOP appeared first on QMDocs Quality Management System Templates.