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

The post Medical Device Human Factor SOP appeared first on QMDocs Quality Management System Templates.

This Standard Operating Procedure (SOP) describes the procedure for conducting Failure Modes and Effects Analysis (FMEA) in order to identify, understand, control, and prevent potential risks in the use of COMPANY Products. FMEA is conducted throughout product design and development. It is one of a series of procedures that support the overall Design Control process.

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         5

4.4       Project Leader (PL) / Head of Engineering (HE)

4.5       Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1       FMEA Process (general)

7.2       FMEA Application

7.3       Severity Levels

7.4       Probability of occurrence

7.5       Probability of detection

7.6       The Risk Index

7.7       The FMEA Team

7.8       The FMEA Process

8          Attachments

FMEA Matrix Summary (1 page)

FMEA Matrix Detail (1 page)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 17 pages procedure

The post FMEA Failure Mode And Effect Analysis appeared first on QMDocs Quality Management System Templates.

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 Changes SOP does not apply to Medical devices in very early stage of development such as early concept or feasibility stages.

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 Changes (general)

7.2      Design Changes Sources

7.3      Design Change Process

7.4      Classes of Change

7.5      Approval of changes

7.6      Changes involving External Organization (EO)

7.7      Design Change Revisions

7.8      Design History File

8          Attachments

Attachment 1: Engineering Change Request Approval and Closure (ECR)

Attachment 2: Engineering Change Request Conduct (ECR) – Sheet 1

Attachment 3: Engineering Change Request Implementation (ECR) – Sheet 2

Attachment 4: Engineering Change Request Cost Estimate (ECR) – Sheet 3

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 21 pages procedure

The post Medical Device Design Changes SOP appeared first on QMDocs Quality Management System Templates.

For the European market, when a device is placed on the market forming a single integral product together with a medicinal product and it is not reusable, it shall be governed by the Medicinal Products Directive 2001/83/EC (MPD) applying the requirements of Annex I to the Medical Devices Directive 93/42/EEC (MDD), as far as safety and performance-related device features are concerned.

General The objective of this SOP is to specify and describe the all necessary system prerequisites for developing and marketing a combination product following 21 CFR Part 4. Regulatory basis, reference documents

• AAMI/ANSI HE74 Human factors design process for medical devices
• AAMI/ANSI HE75 Human factors engineering – Design of medical devices
• IEC 62366Medical Devices – Application of human factors engineering to medical devices
• ISO 14971: Medical Devices – Application of risk management to medical devices
• ISO 9241Ergonomics 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
• ANSI/AAMI/ISO 13485 Medical Devices – Quality Management Systems
• 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
• 21 CFR Part 4 Current Good Manufacturing Practice Requirements for Combination Products
• 21 CFR Part 3 Product Jurisdiction

Table of content

1 Purpose and Objective
2 Regulatory basis, reference documents
3 Responsibility and accountability
3.1 Company Management
3.2 Quality Head and Department
4 Related documents
5 Definitions
6 Procedure
6.1 Medical Device and combination Product in US
6.1.1 Medical Device US
6.1.2 Combination Product US
6.2 Medical Devices and combination product in EU
6.2.1 Medical devices EU
6.2.2 Combination Product EU
6.3 Process deliverables
6.3.1 Risk Management
6.3.2 Design Control
6.3.3 Design Change Control
6.3.4 Purchasing Control
6.3.5 CAPA
6.3.6 Non-conformance / Deviation during Development and Production of Combination Products
6.3.7 Post Market surveillance
6.3.8 Post-approval Phase
6.3.9 Training
6.3.10 Market complaints
7 Attachments
8 SOP distribution
9 Health, safety and environmental considerations

Size and Format: Microsoft Office 2003
Word File 13 pages procedure

The post CFR 4 Medical Device – Combination Product SOP appeared first on QMDocs Quality Management System Templates.

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

The post Development Project Initialization And Design Review appeared first on QMDocs Quality Management System Templates.

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 applies to the Product’s labeling including the User Manual. It does not describe the Verification process for Product software.

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 Verification (general)

7.2      Design Verification Deliverable

7.3      Design Output

7.4      Design Verification Matrix (detail)

7.5      Design Verification Equipment Log

7.6      Design Verification Protocol

7.7      Design Verification Report

7.8      Acceptance of deviations and unresolved Non-conformances

7.9      Approval and Design Review

8          Attachment

Attachment 1:            Design Verification Detail Matrix (1Page)

Attachment 2:            DESIGN VERIFICATION EQUIPMENT LOG (1 Page)

Attachment 3:             DESIGN VERIFICATION REPORT (3 Pages)

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 18 pages procedure

The post Medical Device Design Verification SOP appeared first on QMDocs Quality Management System Templates.

This Design and Development Plan describes the overall development program. The Design Review Committee approves the Development Plan which decribes in detail the complete medical devices 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
• ISO 14971 Medical Devices: Application of Risk Management to Medical Devices

Table of Content

1          Purpose and Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

3.1       Company Management

3.2       Design Review Committee

3.3       Quality Assurance

3.4       Project Leader (PL) / Head of Engineering (HE)

3.5       Function / Area Leaders

4          Related documents

5          Definitions

6          Procedure

Content of a Design and Development Plan

6.1       General

6.1.1    Scope

6.1.2    Applicable to

6.1.3    Goals and Objectives

6.1.4    Intellectual Property Position

6.1.5    Clinical Trials Approach

6.1.6    Facilities and Capital Equipment Required

6.1.7    QA Approach

6.2       Product Description

6.2.1    Description of Product

6.2.2    System Block Diagram

6.2.3    Target Market

6.2.4    Regulatory Approach

6.2.5    Regulatory Approach

6.2.6    Third Party Certification Approach

6.2.7    Packaging and Labeling

6.3       Division of Responsibility and Interfaces

6.4       Project Team

6.4.1   Team members and responsibilities

6.4.2    DRC members

6.5       Activity Schedule, including Deliverables and Key Milestones

6.6       Deliverables for each Phase

6.6.1    Design Input Phase

6.6.2    Design Output

6.6.3    Design Verification

6.6.4    Design Validation

6.6.5    Design Transfer

6.7       Manufacturing

6.7.1    Projected Manufacturing Volume with timeline

6.7.2    Service

6.8       Project Administration

6.8.1    Meeting Frequency

6.8.2    DHF Control

6.8.3    Design Reviews

6          Attachments

7          Plan distribution

8          Health, safety and environmental considerations

Size and Format:

Microsoft Office

2003 Word File

12 pages Plan

The post Medical Device Design And Development Plan appeared first on QMDocs Quality Management System Templates.

Governmental agencies in the world of Medical Devices, in particular the FDA (CDRH), are challenging companies continuously in regard to their Design Control Program. For the recent years it was always one of the top 5 findings in warning letters. The development of a new medical device or main design changes must be managed in a structured environment, which will be the basis of the Design History File (DHF) as well as the Design Master Record (DMR). That is the basis to consistently deliver the intended performance, safety and quality attributes of a medical device. This Design Control Standard Operating Procedure (SOP) is ready to use and meets the expectations of a structured development by guiding the design efforts through well defined input and output phases. The 11-page SOP only needs some minor manufacture or design center specific modification before it can be used for your development.

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

Design Control SOP – 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 Control (general)

7.2 Design and Development Planning

7.3 Phase 2 – Design Inputs

7.4 Phase 3 – Design Outputs

7.5 Phase 4 – Design Verification

7.6 Phase 5 – Design Validation

7.7 Phase 6 – Design Transfer

7.8 Design Changes

7.9 Risk Analysis

7.10 Design History File

7.11 Project Start

7.12 Design and Development Plan

8 Attachments

9 SOP distribution

10 Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 11 pages procedure

The post Medical Device Design Control SOP appeared first on QMDocs Quality Management System Templates.