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.

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 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.