Clinical Evaluation Medical Devices Development

General

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