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.

The objective of this SOP is to describe the pre-market clinical evaluation process of medical devices.

This SOP describes how the clinical evaluation is conducted according to MEDDEV 2.7.1, guideline for clinical evaluation.

All activities relevant for the conduct of a clinical investigation according ISO 14155 are not part of this SOP.

Regulatory basis, reference documents

• MEDDEV2.7.1/Rev.3 : Guideline on medical devices: Clinical evaluation – a guide for manufactures and notified bodies
• EN ISO 14155:2011: Clinical investigation of medical devices for human subjects – Good clinical practice
• Directive 93/42/EEC: Council Directive 93/42/EEC and amendments
• EN ISO 14971 Medical devices – application for risk management to medical devices

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       Medical Scientist

5          Related documents

6          Definitions

7          Procedure

7.1       Introduction to Clinical Evaluation

7.2       General

7.3       Process

7.3.1    Definition of Scope

7.3.2    Essential Requirements

7.3.3    Literature Search

7.3.4    Clinical Experience Data

7.3.5    Clinical Investigations

7.3.6    Analysis of Clinical Data

7.3.7    Conclusion and Report

8          Attachments

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office

Word File

10 pages procedure

The post Clinical Evaluation Medical Devices Development appeared first on QMDocs Quality Management System Templates.

This SOP applies to all medical devices under development after concept and feasibility studies are completed and the COMPANY Management approves the initiation of a Product Development. This SOP applies to all personnel involved in the Management Review as well as for marketed Medical Devices.

Regulatory basis, reference documents

• 21 CFR Part 820, Subpart B – Quality System Regulation, 820.20 Management Responsibility
• ISO 13485:2016: Medical Devices – Quality management systems Requirements for regulatory purposes; 5.6 Management Review
• ISO 9001, Section 6: Resource Management

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       Management Committee Members

4.4       Function / Area Leaders / Project Manager

5          Related documents

6          Definitions

7          Procedure

7.1       Frequency of Management Reviews

7.2       Management Review Inputs (Agenda)

7.3       Management Review Participants

7.4       Management Review Outputs

7.5       Management Review Report and Follow up

8          Attachments

Attachment 1: Management Review Flow chart (1 page)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

Microsoft Office 2003

Word File

15 pages procedure

The post Management Review for Medical Devices appeared first on QMDocs Quality Management System Templates.

This Standard Operating Procedure (SOP) describes the program developed for performing the Hazard Analysis (HA) during the development of Medical Devices under Device Control in order to identify, understand, control, and prevent potential risks in the use of COMPANY Medical Devices. The Hazard Analysis is conducted throughout product design, development as well as marketing/distribution. This SOP is part of the COMPANY Design Control Program, as outlined in the Design Control SOP and supports the overall Design Control process. 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 program 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
• HE75:2009 Human factors engineering – Design of medical devices
• 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

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       General

7.2       Human Factors Engineering

7.3       Hazard Analysis

7.4       Severity

7.5       Probability

7.6       Risk Index

7.7       Hazard Analysis Project team

7.8       Using the Hazard Analysis Matrix Form “Details”

7.9       Using the Hazard Analysis Matrix Form “Summary”

8          Attachments

Attachment 1: Hazard Analysis Matrix Summary (1 page)

Attachment 2: Hazard Analysis Matrix Details (1 page)

Attachment 3: Generic Risk Management graph (1 page)

9          SOP distribution

10        Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 16 pages procedure

The post Hazard Analysis SOP appeared first on QMDocs Quality Management System Templates.

Risk Management begins after concept and feasibility studies are completed and Management approves the initiation of a Product Development Project. 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. The SOP describes on how to perform a risk management process, it provides guidance on how to identify hazards, estimate severity and probability of occurrence of harm as well as to evaluate the corresponding risk and on how to mitigate these risks. The SOP describes on how to handle the residual risks after risk mitigations was implemented. This includes hazard identification covering design, manufacturing, labeling/package, maintenance and disposal of the medical device.

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
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 General
7.2 Risk Mitigation Priorities (general rules)
7.3 Software Risk Analysis
7.4 Risk Analysis File
7.5 Risk Analysis Plan
7.6 Risk Analysis Process
7.7 Functional Analysis (Grey Box)
7.8 Identification of hazards and estimation of risk
7.9 Probability of Occurrence
7.10 Risk Estimation
7.11 Risk Control
7.12 Residual Risk evaluation and Risk benefit Analysis
7.13 Risk Analysis Report
7.14 Post-Production Activities
8 Attachments
Attachment 1: TOC: Risk Analysis Report (1 pages)
Attachment 2: Schematic representation of the Risk Management principle – ISO 14971 (1 page)
Attachment 3: Generic Risk Management graph (1 page)
Attachment 4: Practical Example Risk Management graph (1 page)
9 SOP distribution
10 Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 19 pages procedure

The post Risk Management Process 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.

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

The post Design Transfer 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.