Design Transfer SOP

Design Transfer is the process of transferring product design information (Production Specifications) to Manufacturing for the purposes of manufacturing the medical device. This is not a single event but happens throughout the whole design process in the form of documentation and training. Nevertheless the design transfer must be formalized and demonstrate verification and validation are successful at e.g. a pilot production run to determine the adequacy of full‑scale manufacturing. With that it can be assured that the medical device can be repeatedly and reliably manufactured within product and process capabilities using the specifications as transferred to Manufacturing. The successful process and documentation is of high interest for any regulatory inspection like FDA and a potential gap to fail the authorities’ expectations.

 

Scope:

This SOP applies to all personnel who are working under Design Controls including such medical devices being part of the design transfer activities.

 

Objective:

This Standard Operating Procedure (SOP) describes the Medical Devices Design Transfer, including all activities required to initiate manufacturing of a new medical device. The SOP describes the process and the activities necessary translating design documentation into manufacturing documentation and prepares the manufacturing operations for full scale manufacturing.

 

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 Definitions

6 Procedure

6.1 Design Transfer (general)

6.2 Design Transfer essentials

6.3 Design Transfer team and reviews

6.4 Design Transfer process and outputs

6.5 Design Transfer Documentation (Device Master Record)

6.6 Design History File

7 Attachments

8 SOP distribution

9 Health, safety and environmental considerations

 

Size and Format:

• Microsoft Office 2003
• Word File
• 9 pages procedure, no attachment