Development Project Initialization And Design Review

General

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 Controls SOP does not apply to medical devices in very early stage of development such as early concept or feasibility stages. Design Controls begin after concept and feasibility studies are completed after the Company Management approves the initiation of a Product Development Project.

 

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
• 21 CFR Part 820-Quality system Regulation, Subpart G- Production and Process Controls

 

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 / Head of Engineering

4.5 Function / Area Leaders

5 Related documents

6 Definitions

7 Procedure

7.1 Development Project Initialization

7.2 Design Review (general)

7.3 Design Review Elements

7.4 Design Review Approval

7.5 Design Review Documentation

8 Attachments

Attachment 1: Design Review Summary Form (1 pages)

Attachment 2: Development Initiating Project Form (2 pages)

9 SOP distribution

10 Health, safety and environmental considerations

 

Size and Format:

• Microsoft Office 2003
• Word File
• 13 pages procedure