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.

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.

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 does not describe the validation process for Product Software or clinical testing.

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  5

4.4      Project Leader / Head of Engineering

4.5      Function / Area Leaders

5          Related documents

6          Definitions

7          Procedure

7.1      Design Validation (general)

7.2      Design Validation Deliverables

7.3      Design Validation Matrix (Part 1)

7.4      Design Validation Equipment Log

7.5      Design Validation Protocol

7.6      Design Validation Report

7.7      Acceptance of deviations and unresolved Non-conformances

7.8      Approval and Design Review

7.9      Design Validation Matrix (Part 2)

8          Attachments

Attachment 1: Design validation matrix (3page)

Attachment 2: Design validation equipment log (1 page)

Attachment 3: Design validation protocol (2 pages)

Attachment 4: Design validation protocol – report template (3 pages)

Attachment 5: Design validation failure template (2page)

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 24 pages procedure

The post Medical Device Design Validation 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

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 Output (general)

7.2      Design Output Process

7.3      Design Output Approval

8          Attachments

Design outputs and verification matrix (1 page)

9          SOP distribution

10       Health, safety and environmental considerations

Size and Format:

• Microsoft Office 2003
• Word File
• 10 pages procedure

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

This Medical Device Design Inputs 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 of the Medical Device Design Inputs SOP:

• Microsoft Office 2003
• Word File
• 13 pages procedure

The post Medical Device Design Inputs 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.

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.