Medical Device Design Validation SOP

In stock
Medical Device Design Validation SOP

 This Standard Operating Procedure (SOP) describes the program necessary to validate the design of COMPANY products against User Requirements. This Standard Operating Procedure (SOP) describes the This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP.



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.

This SOP does not describe the validation process for Product Software or clinical testing.


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  5

4.4      Project Leader / Head of Engineering

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Validation (general)

7.2      Design Validation Deliverables

7.3      Design Validation Matrix (Part 1)

7.4      Design Validation Equipment Log

7.5      Design Validation Protocol

7.6      Design Validation Report

7.7      Acceptance of deviations and unresolved Non-conformances

7.8      Approval and Design Review     

7.9      Design Validation Matrix (Part 2)

8          Attachments

            Attachment 1: Design validation matrix (3page)

            Attachment 2: Design validation equipment log (1 page)

            Attachment 3: Design validation protocol (2 pages)

            Attachment 4: Design validation protocol – report template (3 pages)

            Attachment 5: Design validation failure template (2page)

9          SOP distribution

10       Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 24 pages procedure
Write Your Own Review
You're reviewing:Medical Device Design Validation SOP