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.

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 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.

The purpose of this Compliance Checklist CFR 820 is to verify that a organisation is complainant to 21 CFR 820 Quality System Regulations. This evaluation checklist can be used as part of a supplier evaluation or audit process or as an checklist for internal auditing or to perform a gap analysis as part of any compliance program or inspection readiness initiative.

US Food and Drug Administration (FDA) 21 Code of Federal Regulations (CFR) part 820

Table of Content:

1          Purpose & Objective

2          Regulatory basis, reference documents

3          Responsibility and accountability

4          Definitions

5          Procedure

5.1       820.20 – Management Responsibility

5.2       820.22 – Quality Audits

5.3       820.25 – Personnel

5.4       820.30 – Design Controls

5.5       Design and Development planning

5.6       Design Input

5.7       Design Output

5.8       Design Reviews

5.9       Design Verification

5.10      Design Validation

5.11      Design Transfer

5.12      Design History File

5.13      820.40 – Document Controls

5.14      820.50 – Purchasing Controls

5.15      820.60 – Identification

5.16      820.65 – Traceability

5.17      820.70 – Production and Process Controls

5.18      820.72 – Inspection, Measuring, and Test Equipment

5.19      820.75 – Process Validation

5.20      820.80 – Receiving, in-process, and finished device acceptance

5.21      Receiving acceptance activities

5.22      In-Process acceptance activities

5.23      Final Acceptance Activities

5.24      820.86 – Acceptance Status

5.25      820.90 – Non-Conforming Product

5.26      820.100 – Corrective and Preventive Action

5.27      820.120 – Device Labeling

5.28      820.130 – Device Packaging

5.29      820.140 – Handling

5.30      820.150 – Storage

5.31      820.160 – Distribution

5.32      820.170 – Installation

5.33      820.180 – General Requirements

5.34      820.181 – Device Master Record

5.35      820.184 – Device History Record

5.36      820.186 – Quality System Record

5.37      820.198 – Complaint Files

5.38      820.200 – Servicing

5.39      820.250– Statistical Techniques

6          Attachments

Size and Format of the Compliance Checklist CFR 820:

• Microsoft Office 2003
• Word File
• 24 pages checklist – gap analysis

The post Compliance Checklist CFR 820 appeared first on QMDocs Quality Management System Templates.

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       Design Review Committee

4.2       Quality Assurance

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

4.4       Function / Area Leaders

5     Related documents

6     Definitions

7     Procedure

7.1       General Maintenance of Design History File

7.2       Content of the DHF

7.3       Day to day DHF work

7.4       Numbering of the Design History File

7.5       Security of Design History File Information

8     Attachments

9     SOP distribution

10         Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 8 pages procedure

The post Design History File (DHF) SOP appeared first on QMDocs Quality Management System Templates.