Medical Device Design Inputs

In stock
Medical Device CFR 820 Design Inputs

This Standard Operating Procedure (SOP) describes the Design Input which is part of the Design Control process by which the activities associated with the planning, design, and development of a new medical device are controlled and documented.



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


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 Inputs (general)

7.2      Design Input - User Requirements

7.3      Design Input - Product Requirements   

7.4      Approving Design Input Documents

7.5      Product Requirements Form (PRS)

7.6      Design History File

8          Attachments (3 pages)  Product Requirements Specification Form

9          SOP distribution

10       Health, safety and environmental considerations


Size and Format:

  • Microsoft Office 2003
  • Word File
  • 13 pages procedure

Write Your Own Review
You're reviewing:Medical Device Design Inputs