The objective of this SOP is to specify the Human Factors Engineering and Design Validation process to ensure that medical devices are designed according to user requirements and that the use of the device (including labelling, packaging and USER information) is safe, effective, efficient and satisfying. To successfully launch new medical devices this process needs to be in compliance with current regulatory expectations.

Regulatory basis, reference documents

• AAMI/ANSI HE74:2001 Human factors design process for medical devices
• AAMI/ANSI HE75:2009 Human factors engineering – Design of medical devices
• IEC 62366:2007 Medical Devices – Application of human factors engineering to medical devices
• ISO 14971:2007 Medical Devices – Application of risk management to medical devices
• ISO 9241:2010 Ergonomics of human-system interaction – Part 210: Human-centred design for interactive systems
• Food and Drug Administration, CDRH: Do it by design: An introduction to Human Factors in Medical Devices
• Food and Drug Administration, CDRH: Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management, 2000
• ANSI/AAMI/ISO 13485:2016  Medical Devices – Quality Management Systems
• AAMI HE48:1993 Human factors engineering guidelines and preferred practices for the design of medical devices
• Food and Drug Administration, CDRH: Write it right: Recommendations for developing user instruction manuals for medical devices used in home health care
• 21 CFR Part 820: Quality System Regulation

Table of Content (just Headers):

1          Purpose

2          Objective

3          Regulatory basis, reference documents

4          Responsibility and accountability

4.1       Company Management

4.2       Quality Head and Department

4.3       Human Factors Specialist

5          Related documents

6          Definitions

7          Procedure

7.1       General

7.2       Process deliverables

7.2.1    Intended Use / Application Specification

7.2.2    Device Specification

7.2.3    Design Input and Design output

7.3       Task Analysis and Use Error Identification

7.4       Usability Specification

7.5       Testing Activities

7.5.1    Usability Evaluation Study

7.5.1    Usability Evaluation Study

7.5.2    Design Validation Study

8          Attachments

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office 2003

Word File

10 pages procedure

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