This SOP applies to all Medical devices that are approved for Product Development as well as to the personnel who are responsible for implementing Design Controls for such Medical devices. This Design Changes SOP does not apply to Medical devices in very early stage of development such as early concept or feasibility stages.

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      Company Management

4.2      Design Review Committee

4.3      Quality Assurance

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

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Changes (general)

7.2      Design Changes Sources

7.3      Design Change Process

7.4      Classes of Change

7.5      Approval of changes

7.6      Changes involving External Organization (EO)

7.7      Design Change Revisions

7.8      Design History File

8          Attachments

Attachment 1: Engineering Change Request Approval and Closure (ECR)

Attachment 2: Engineering Change Request Conduct (ECR) – Sheet 1

Attachment 3: Engineering Change Request Implementation (ECR) – Sheet 2

Attachment 4: Engineering Change Request Cost Estimate (ECR) – Sheet 3

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 21 pages procedure

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