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.